Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient

NCT07140133 | Not Yet Recruiting DMC

• 1 other identifier: 38RC25.0204
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Rate of occurrence of combined endpoint at 335 days: net averse clinical event (death from any cause, infarction and non-fatal stroke) + (BARC major bleeds >3)).

  Validate the non-inferiority of the frequency of occurrence at 335 days after a short DAPT (1 month) of a combined endpoint, net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds \>3) occurring in patients implanted with an HT supreme™ coronary stent in HBR patients to the ultimaster stent (Terumo)

  At 335 days

Secondary Outcomes (10)

• Comparison of primary endpoint (net averse clinical event (all-cause death, non-fatal MI and non-fatal stroke) + (BARC major bleeds >3) ) frequency in patients with HBR and high ischemic risk.

  At 335 days and one year

• Evaluate the one-year frequency of death from any cause

  At 335 days and one year

• Evaluate the one-year frequency of cardiovascular deaths

  At 335 days and one year

• Evaluate the one-year incidence of myocardial infarction

  At 335 days and one year

• Evaluate the one-year incidence of ischemic stroke

  At 335 days and one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for coronary angiography and meeting the inclusion criteria will be recruited in the cardiology departments of participating centers.

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Sino Medical Sciences Technology Inc.: collaborator

Study Sites (1)

Chu Grenoble Alpes

Grenoble, Isère, 38700, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

FR (1)