[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centro per la Lotta Contro l'Infarto - Fondazione Onlus\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100601766","renal-denervation-after-stroke-reds-study---a-randomized-clinical-trial-of-renal-denervation-in-the-subacute-phase-of-stroke-100601766",false,"NCT07114757","REnal Denervation After Stroke (REDs) Study - A Randomized Clinical Trial of Renal Denervation in the Subacute Phase of Stroke","REDs","Inclusion Criteria:\n\n\\- We will enroll patients (at least 18 years of age and younger than 85 years old) with subacute stroke (thus occurring 7-45 days before screening), admitted to hospital, with persistently high systolic PB (≥140 mm Hg computed as the mean of 3 repeated measurements taken within 5 minutes between 8.00am and 8.30 am on 2 consecutive days, thus totaling 6 measurements), or a non-dipper profile at ambulatory BP monitoring, despite therapy with ≥2 anti-hypertensive drugs at maximum tolerated dose. Patients should be medically stable with no severe complications such as infections, or worsening of neurological status that would require immediate and intensive medical or surgical intervention.\n\nExclusion Criteria:\n\n* ⦁ Patients with cerebral bleeding due to arteriovenous malformation or intracranial aneurysm\n\n  * Hemodynamic instability\n  * Comorbidity with life expectancy ≤ 1 year\n  * Renal artery anatomy, which prevents the procedure\n  * Reno vascular disease\n  * Vascular occlusion, which prevents the procedure\n  * Secondary hypertension\n  * Subject has known hypersensitivity or contraindication to any of the study drugs\n  * The subject is currently participating in another investigational drug or device clinical study\n  * Pregnancy or nursing\n  * Presence of other anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements or impact the scientific soundness of the clinical investigation results","ALL","18 Years","84 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"NA","The REnal Denervation after stroke (REDs) study is a national, multicenter, investigator-initiated randomized controlled clinical trial designed to assess the efficacy of catheter-based renal denervation (RDN) performed in the subacute phase of stroke among patients with drug-resistant hypertension. Conducted across 15 Italian centers, this pragmatic trial adopts a parallel-group design with participants randomized in a 1:1 ratio to receive either RDN using the Symplicity Spyral system or standard care. Randomization will occur via a secure online platform, and the intervention will be performed within 24 hours post-randomization, adhering to a standardized procedural protocol.\n\nThe trial targets adult patients aged 18 to 84 years who have experienced a stroke 7 to 45 days prior to enrollment and present with persistent systolic hypertension (≥140 mmHg) or a non-dipping profile on ambulatory blood pressure monitoring, despite the use of at least two antihypertensive medications at maximum tolerated doses. Following informed consent and verification of eligibility, enrolled patients will undergo baseline assessments including physical examination, laboratory testing, ECG, stroke severity and disability scoring, and quality of life evaluation.\n\nThe total duration of the REDs study is 48 months, encompassing a 24-month enrollment window and a 24-month follow-up period. Study endpoints, including 24-hour ambulatory blood pressure and secondary clinical and functional outcomes, will be evaluated at 3, 6, 9, 12, and 24 months following the intervention. These follow-up assessments will be conducted through hospital visits or teleconsultations as appropriate.\n\nThe primary efficacy endpoint is the change in mean 24-hour systolic blood pressure 12 months after randomization. Secondary endpoints include diastolic and mean arterial pressure, antihypertensive medication burden, time to blood pressure control, functional neurological scores (NIHSS, mRS), quality of life metrics, and stroke recurrence. Data collection will be managed via an electronic case report form (eCRF), and adverse events will be monitored throughout the study in line with ISO14155 and GCP standards.\n\nThis trial is supported by an unrestricted grant from Medtronic and adheres to ethical guidelines as outlined by the Declaration of Helsinki and GDPR. The REDs study aims to generate clinically relevant evidence to support the integration of RDN into secondary prevention strategies for stroke patients with resistant hypertension.",[27,28,29,30,31,32],"Cardiovascular Diseases","Cerebrovascular Disease","Arterial Hypertension","Hypertension","Renal Denervation","Stroke","NOT_YET_RECRUITING","2025-08-04",{"date":36,"type":37},"2025-08-11","ACTUAL",{"date":39,"type":21},"2025-09-25",{"date":41,"type":21},"2029-09-25",{"name":43,"class":44},"Centro per la Lotta Contro l'Infarto - Fondazione Onlus","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100441409","interventional-strategy-for-non-culprit-lesions-with-major-vulnerability-criteria-at-oct-in-patients-with-acs-100441409","NCT05027984","Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS","An Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome (the INTER-CLIMA Trial)","INTERCLIMA","Inclusion Criteria:\n\n* Age of at least 18 years.\n* Diagnosis of acute coronary syndrome.\n* Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment with no other significant stenosis (\\>70%) in the same vessel.\n* Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site.\n* Life expectancy \\>3 years.\n\nExclusion criteria:\n\n* Female with childbearing potential or lactating.\n* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg\u002Fdl).\n* Advanced heart failure (NYHA III-IV)\n* Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time.\n* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial.\n* Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges).\n* Lesions located in the left main coronary artery\n* Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries.\n* Prior myocardial infarction or coronary artery bypass graft \\[CABG\\] or PCI revascularization in the target coronary vessel.\n* Coronary anatomy unsuitable for PCI.\n* Comorbidities that might interfere with completion of the study procedures.\n* Planned major surgery necessitating interruption of dual antiplatelet.\n* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.",{"count":55,"type":21},1420,[24],"The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve\\[FFR\\]\u002Finstantaneous Wave-Free Ratio\\[iFR\\]\u002Fresting full-cycle ratio\\[RFR\\]) treatment of intermediate (40-70% diameter stenosis), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1420 patients with ACS will be randomized into the study at approximately 40 sites worldwide.",[59,60,61],"Coronary Artery Disease","Coronary Disease","Ischemic Heart Disease",[63,64,65],"Coronary artery disease","Optical coherence tomography","Vulnerable plaque","RECRUITING","2025-07-23",{"date":69,"type":37},"2025-07-28",{"date":71,"type":37},"2021-06-30",{"date":73,"type":21},"2028-03-31",{"name":43,"class":44},34,""]