Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
High risk of bleeding (HBR) is a determining factor for the duration of dual antiplatelet therapy (DAPT). Recent studies have shown that the use of one-month DAPT is beneficial in terms of ischemic as well as hemorrhagic events, particularly in HBR patients, compared with longer DAPT. European guidelines therefore authorize one-month DAPT in HBR patients presenting even an acute coronary syndrome.
The HT Supreme Drug Coated Coronary Stent System (HT Supreme DES) is designed to promote reendothelialization as quickly as possible. That's why the stent is called "HT" Supreme, with "HT" standing for "Healing Targeted", enabling a DAPT of just 1 month in all-comers HBR patients.
Thanks to these features, the investigators aim to demonstrate ischemic and hemorrhagic complication rates lower than those found in the literature with other stent.
Eligibility criteria
Qualifiers
Patient aged ≥ 18 years
Male or female patient requiring a coronary angioplasty procedure according to European recommendations,
Patients undergoing revascularization with HT-supreme stents
Patient at high risk of bleeding according to ARC HBR definition (9).
Disqualifiers
Estimated lifespan <1 year,
Allergy and any other contraindication to aspirin and/or clopidogrel listed in the summary of product characteristics,
Allergy to iodinated contrast media
Adults under legal protection (guardianship, curatorship or safeguard of justice).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
University Hospital, Grenoble
Lead sponsor
Sino Medical Sciences Technology Inc.
Collaborator
Source ClinicalTrials.gov