Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population

Cardiac Disease Clinical Trial

Official title: Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in High Bleeding Risk PCI Population

Status Completed

Clinical Trial Summary

The study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).

Clinical Trial Description

Study design: An Investigator-initiated, multi-center, randomized clinical trial in HBR patients receiving PCI with Supraflex Cruz or Ultimaster Tansei stents

Study population: 2 x 368 (736) patients, who undergo a PCI and are at high risk for bleeding (HBR).

Intervention: Patients are treated according to the randomized regimen at index PCI and at planned staged procedures. Either with the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent

DAPT treatment (combination and duration) is according to the Guidelines of the European Society of Cardiology for Myocardial Revascularization.

Follow-up is scheduled at 1 month, 6 months and 12 months post index PCI procedure.

Primary study parameters/outcome of the study:

The primary endpoint Net Adverse Clinical Endpoints (NACE) defined as a composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke and bleeding events defined as BARC 3 or 5 at 12 months follow-up after the index PCI. ;

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Hemorrhage
• High Bleeding Risk
• PCI

• NCT number: NCT04500912
• Study type: Interventional
• Source: Research Maatschap Cardiologen Rotterdam Zuid
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Completion date: September 1, 2023