Percutaneous Coronary Intervention (PCI)

This is a randomized, controlled study. ACS follow- up patients aged 18 to 80 years old with hemodynamic stability, who are 14 days to 1 year after PCI, are screened through the HAMD score and the HAMA score. Patients with a HAMD score greater than 7 points and a HAMD score higher than that of the HAMA, are included in this study. Patients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 20 minutes each time, twice a day with an 8-week treatment and a 8-week follow-up. All treatments were self-administered by the patients at home after they received training from the hospitals. The primary observation endpoints include the depression scores of the HAMD. The secondary observation endpoints include the HAMA 、GAD、 response and remission rates of HAMD ，as well as the PCL-C for post-traumatic stress disorder. We also observed the cardiac function indexes measured by echocardiography and the B-type natriuretic peptide .

AID Post-PCI Angina is as an observational, prospective, single-cohort, multicenter study designed to investigate the causes and origins of post-PCI angina by using the advance invasive diagnosis (AID) strategy combining with angiography derived physiology (ADP) in an all-comers population of patients with post-PCI angina referred for invasive coronary angiography. An all-comers population of patients with a history of previous percutaneous coronary intervention (PCI), who presented with angina or documented myocardial ischemia by non-invasive testing and are referred for invasive coronary angiography (ICA) will be enrolled. ICA will be performed with the application of the structure AID strategy to evaluate both obstructive and non-obstructive cause of myocardial ischemia. Then, angiography derived physiological assessment of epicardial coronary artery using functional coronary angiography in each vessel will be performed in both index procedure and the previous procedure in all patients. By combining information obtained from both procedures, the causes and origins of post-PCI angina will be made. Treatment will be decided by the operators according to the result. Patients will complete the Seattle Angina Questionnaire (SAQ) at baseline and at 1, 6, and 12 months after the procedure. The main hypothesis of this study states that, in patients with post-PCI angina referred to ICA, the application of the structured AID strategy combining with angiography derived physiology (ADP) will lead to a high diagnostic yield in identifying the origins of obstructive disease and causes of post-PCI angina.

The primary objective of the study is to assess the safety and the efficacy of a hybrid percutaneous coronary intervention (PCI) strategy combining a magnesium-based sirolimus-eluting bioresorbable scaffold (Freesolve, Biotronik AG, Switzerland) and ≥1 paclitaxel-eluting drug-coated balloon(s) (Pantera Lux, Biotronik AG, Switzerland) compared to a conventional DES-based PCI approach using \>1 newer-generation drug-eluting stents (Orsiro Mission, Biotronik AG, Switzerland) for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI with respect to vessel-level absolute change in non-invasive angiography-derived fractional flow reserve (FFRangio, CathWorks, Newport Beach, USA) between post-index PCI and 12-month follow-up. BIOHYBRID is a coronary revascularization strategy study comparing two contemporary treatment approaches for patients with long and/or diffuse coronary artery lesions undergoing PCI. The primary hypothesis of the study is that a hybrid PCI strategy using a 'leave nothing behind' or 'metal-free' approach that combines a bioresorbable magnesium scaffold and drug-coated balloons for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI is feasible. The secondary hypothesis is that a hybrid PCI strategy combining a bioresorbable magnesium scaffold and drug-coated balloons is non-inferior to a conventional DES-based PCI approach using one or several DES for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI with respect to vessel-level absolute change in FFRangio (CathWorks, Newport Beach, USA) between post-index PCI and at 12 months of follow-up.

Implantation of a metallic drug-eluting stent (DES) is currently the gold standard in percutaneous coronary intervention (PCI). However, a DES has several limitations on the long-term, such as chronic local inflammation which may lead to in-stent restenosis, absence of physiological coronary vasomotion and vessel caging which makes future coronary artery bypass grafting (CABG) impossible. A bioresorbable scaffold (BRS) is designed to overcome these limitations. The first generation BRS was shown to be clinically inferior to DES due to a slightly higher rate of stent thrombosis. To overcome this problem, several scientific developments have been achieved in the past few years, such as thinner BRS strut construction and improved implantation technique by using PSP (predilatation, sizing, postdilatation) method and intracoronary imaging guidance with optical coherence tomography (OCT) or intravasculair ultrasound (IVUS). A PCI protocol that combines implantation of a second generation thin-strut BRS, mandatory PSP implantation method and mandatory intracoronary imaging-guidance has not yet been investigated. The aim of this study is to investigate feasibility of a new PCI protocol with implantation of the second generation Meres100 thin-strut BRS combined with a protocolized PSP implantation technique guided by intracoronary imaging.

This is a prospective, multicenter, observational registry designed to evaluate clinical outcomes in patients undergoing complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) in China. Eligible patients will be adults with complex coronary artery disease and severely reduced left ventricular function, or reduced left ventricular function with severe mitral regurgitation, who are considered by the heart team to have an indication for coronary revascularization but are at high risk for coronary artery bypass grafting or decline surgical revascularization. The registry will collect baseline clinical characteristics, coronary angiographic and procedural data, use of intravascular imaging or physiological assessment, revascularization strategy, mechanical circulatory support, peri-procedural complications, laboratory and echocardiographic data, and follow-up outcomes. The primary endpoint is all-cause mortality at 1 year after PCI. Secondary endpoints include major adverse cardiovascular events, cardiac death, myocardial infarction, target vessel revascularization, heart failure hospitalization, major bleeding, and quality-of-life measures. The study also aims to identify prognostic factors and develop a risk prediction model for patients undergoing CHIP-PCI.

Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined. The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant. In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events. In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").

The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon \[DCB\] strategy with bail-out BioResorbable Scaffold \[BRS\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \[NSTEMI\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are: DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy? Participants will be followed at: 1. st FU visit - 1 month (in hospital) 2. nd FU visit - 6 months (telephone) 3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint 4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy 5. th FU visit - 730 days±30 days (telephone call) - 2Y 6. th FU visit - 1095 days±30 days (telephone call) - 3Y 7. th FU visit - 1460 days±30 days (telephone call) - 4Y 8. th FU visit- 1825 days±30 days (telephone call) - 5Y

The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN), identified by optical coherence tomography (OCT), causing significant angiographic stenosis and eligible for revascularization through percutaneous coronary intervention (PCI). Patients will be randomized in a 1:1 ratio to undergo lesion preparation with either orbital atherectomy (OA) or intravascular lithotripsy (IVL). The aim of this pilot trial is to compare PCI outcomes and the incidence of adverse events between both techniques.

Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight. Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS). Study design: Open-label, single-centre, randomized controlled trial. Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome. Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin. Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.

Endothelial dysfunction is one of the aetiological factors in ischaemic heart disease (IHD). Aerobic exercise is effective in improving endothelial function, as measured by flow-mediated dilation (FMD), in patients with IHD. Within the aerobic exercise methods, there is evidence showing that high-intensity interval training (HIIT) increases FMD to a greater extent than moderate-intensity training (MIT) in these patients. Notably, in a recent review, our research group found that only studies performing long bouts of HIIT (long HIIT: higher than 1 min) found a greater effect on FMD, while no differences were found in those studies using short bouts of HIIT (short HIIT: ≤ 1 min) and MIT. However, no experimental studies comparing the effect of long HIIT, short HIIT, and MIT on endothelial function, as well as other predictors of mortality, such as cardiorespiratory fitness, brain-derived neurotrophic factor (BDNF) levels or parasympathetic branch activity, have been performed. Therefore, the main objective of this project will be to compare the effect of the three aerobic exercise methods on endothelial function, as measured by FMD, in patients with IHD. Complementarily, the effect of aerobic exercise, depending on the exercise method, on different mortality predictors will be compared. For this purpose, a multicentre randomised study will be carried out (2 hospitals in Elche and one in Alicante). Assessors will be blinded to the patients allocation. Participants will be aware about their allocation in the experimental groups due to the nature of the study. A total of 132 men and women with IHD (66 per sex), diagnosed between three and 12 months before the start of the intervention, aged between 45 and 75 years, and without limitations for the practice of exercise training, will be recruited. All patients will train 3 days a week for 12 weeks. Participants will be assessed before the intervention (i.e., pre), at 6 weeks of training (i.e., mid) and after the intervention (i.e., post). Physiological and psychological variables will be registered in the assessment periods. Training intensity will be individually prescribed based on the cardiopulmonary exercise test (CPET). Intensity exercise will be adapted after the first part of the intervention. Analysis of covariance will be used to compare the values of the three groups after the intervention for the continuous variables, including the pre-intervention value as a covariate, while a logistic regression model will be used for the categorical variables.

Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.

The goal of this observational study is to assess the diagnostic performance of 3D Stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention. The main question it aims to answer is: The study hypothesis is that 3DStent technology will offer a comparable assessment of stent expansion compared to intravascular imaging.

Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis. International guidelines recommends non-compliant and very-high-pressure balloons, which lead to sub-optimal angiographic and clinical results. Recently, observational studies have suggested the feasibility and safety of intravascular lithotripsy (IVL) in UE treatment. There are no prospective randomised controlled studies comparing intravascular lithotripsy with balloons in ISR with UE.

The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.

The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.

The goal of this clinical trial is to learn if reducing the duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (short treatment regimen, stopping aspirin at day 7) is as safe and efficient as the standard DAPT duration (standard treatment regimen) in elderly patients ≥ 65 years. The main questions it aims to answer are: Does the reduction of the duration of DAPT reduces rates of bleeding without increasing the risk of cardiovascular events? Researchers will compare a short treatment by DAPT (7 days, followed by single antiplatelet therapy) to a standard treatment duration by DAPT (3 to 12 months) after successful percutaneous coronary intervention with ≥ 1 drug-eluting stent. Participants will: * Take aspirin for 7 days in one group or 3 to 12 months in another group * Be contacted by phone at 7 days, 14 days, 21 days, 30 days, 3 months, 6 months and 12 months after hospital discharge * Keep a diary of any bleeding or cardiovascular events occurring during the study period

This study aims to evaluate the value of Shexiang Baoxin Pill (MUSKARDIA) in patients with acute myocardial infarction (AMI) through a prospective, multicenter, pragmatic randomized controlled real-world study. It seeks to validate its efficacy in reducing cardiovascular event risk during the peri-PCI period, as well as its effects on cardiac function, quality of life , and relevant biomarkers. Through this research, we expect to provide higher-quality evidence for the application of SBP in AMI patients undergoing PCI, thereby further optimizing comprehensive treatment strategies for AMI.

Cardiac rehabilitation has proven to improve the functional capacity of patients who had acute myocardial infarction. However, its effect on Left ventricular remodeling following an MI event treated with Primary PCI is not yet fully understood. So, for this randomized controlled trial our objectives are as follows: * Primary: To assess the effect of a structured CR program on LV remodeling parameters (LVEF, LVESV, LVEDV, LVESD, LVEDD + SWMA) in STEMI patients treated with primary PCI. * Secondary: To evaluate changes in exercise capacity, heart rate recovery and clinical outcomes such as major adverse cardiovascular events and the effect of CR on the patients' Quality of Life. These results will be compared to the same parameters in a control group that will not undergo cardiac rehabilitation to properly assess the effect of cardiac rehab. Participants in the intervention group will be asked to undergo a supervised CR program based on published guidelines (FITT principle). The core will be a moderate-intensity aerobic exercise regimen (e.g. treadmill or cycle ergometer) 2-3 times per week for 12 weeks. Each session will last \~20-60 minutes of exercise followed by cool-down, with intensity gradually increased to High intensity interval training (HIIT) in low-moderate risk individuals, as it has shown better improvement in cardiovascular health while being safe in MI patients. Resistance exercises (e.g. light weights or band exercises) will also be included twice weekly. Exercise dose (frequency, intensity, time) will be tracked. Physical therapists will supervise all sessions in an outpatient CR facility or affiliated gym. Patients' vitals and ECG will be monitored during initial sessions for safety.

This prospective, multicenter, single-arm, interventional study evaluates the effectiveness and safety of Medipixel XA-Assisted Percutaneous Coronary Intervention (MPXA-PCI) in patients with coronary artery disease (CAD). The study aims to assess procedural success rates and clinical outcomes associated with the novel MPXA-assisted PCI strategy in a real-world clinical setting. A total of 830 patients with de novo coronary lesions eligible for drug-eluting stent (DES) implantation will be enrolled. All participants will undergo MPXA-assisted lesion assessment to optimize balloon and stent selection. The primary outcome is target vessel failure (TVF) at 12 months, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. Secondary outcomes include procedural success, angiographic results, and periprocedural complications. This study will provide evidence regarding the clinical applicability and safety of artificial intelligence-assisted quantitative coronary analysis (AI-QCA) technology for optimizing PCI procedures.

The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation. The main disadvantage of the historical Crush technique is the low success rate of the final kissing balloon inflation. An improvement came with the introduction of double kissing crush stenting aiming for the shorter protrusion and kissing balloon dilation performed before and after main branch stent implantation. The double kissing crush provides a significant reduction in major adverse cardiovascular events compared to Provisional stenting, Crush, and Culotte techniques. Recently, a novel modified mini-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired, and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon), and this causes less disruption of the stent cells. To date, no data compares the mid-term outcomes of double kissing crush and controlled balloon-crush stenting techniques in patients with complex coronary bifurcation lesions. Hence, this study aimed to determine the clinical results of double kissing crush and controlled balloon-crush techniques under mid-term follow-up.

The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting Xience or Promus stents) in a population-based setting with coronary artery stenosis treated with percutaneous coronary intervention

This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). The main outcomes measured will include major adverse cardiovascular and cerebrovascular events (NACCE), bleeding events, and target vessel failure (TVF). The goal is to evaluate whether a shorter duration of DAPT is non-inferior to the standard 12-month regimen in preventing ischemic events while reducing the incidence of bleeding.