NCT04500912

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 736 (actual)
• Sponsor: Pieter C.Smits · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Cardiac Disease
• PCI
• High Bleeding Risk

Interventions

Type	Name	Description
DEVICE	Supraflex Cruz 60 Micron	percutaneous coronary intervention
DEVICE	Ultimaster Tansei 80 Micron	percutaneous coronary intervention

Timeline

• Start date: 2020-09-14
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2020-08-05
• Last updated: 2023-09-15

Locations

11 sites across 1 country: Netherlands