Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient

NCT ID: NCT07140133

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-09-30

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sino Medical Sciences Technology Inc.

INDUSTRY

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Grenoble Alpes

Grenoble, Isère, France

Countries

France

Facility Contacts

Clémence Charlon

Role: primary

ccharlon@chu-grenoble.fr

0476766823

Other Identifiers

38RC25.0204

Identifier Type: -

Identifier Source: org_study_id