Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient (DIOHR)

Grenoble Alpes University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: DAPT(Dual Antiplatelet Therapy); Cardiology; High Bleeding Risk Patients; Stent Implantation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07140133

38RC25.0204

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).
• Patient affiliated to or benefiting from a social security scheme
• Patient who does not object to research

Exclusion criteria

• 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).
• Persons deprived of their liberty by judicial or administrative decision,
• Patient in a period of relative exclusion from another research protocol,