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

Not Applicable

Completed

• Conditions: Cardiac Disease; PCI; High Bleeding Risk
• Interventions: Device: Ultimaster Tansei 80 Micron; Device: Supraflex Cruz 60 Micron

• Registration Number: NCT04500912
• Lead Sponsor: Pieter C.Smits

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-05
• Study Start: 2020-09-14
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 736

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultimaster Tansei stent	Ultimaster Tansei 80 Micron	Randomization to Ultimaster Tansei stent
Supraflex Cruz stent	Supraflex Cruz 60 Micron	Randomization to Supraflex Cruz stent

Primary Outcome Measures

Name	Time	Method
Net Adverse Clinical Endpoints (NACE)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
The composite of cardiovascular death, myocardial infarction, stroke and major bleed BARC 3 and 5	1 year	The composite of cardiovascular death, myocardial infarction, stroke and major bleed according to BARC 3 and 5
Bleeding events	1 year	Bleeding events according to the BARC, TIMI and GUSTO classification
Transfusion rates	1 year	Transfusion rates both in patients with and/or without clinically detected over bleeding
Target vessel failure (TVF)	1 year	Target Vessel Failure (TVF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target vessel revascularization
Stent thrombosis	1 year	Stent thrombosis according to the ARC definitions
Myocardial infarction	1 year	Myocardial infarction.
Event rates according to the PRECISE-DAPT	1 year	Event rates according to the PRECISE-DAPT score
The composite of cardiovascular death, myocardial infarction and stroke	1 year	The composite endpoint of cardiovascular death, myocardial infarction and stroke
Urgent target vessel revascularization	1 year	Urgent target vessel revascularization.
Non-target vessel revascularization	1 year	Non-target vessel revascularization.
Clinically indicated target vessel revascularization	1 year	Clinically indicated target vessel revascularization.
Procedural success	At completion of the baseline PCI	Procedural success is defined as angiographic success with no in-hospital MACE, defined as death, MI with new Q-waves on electrocardiogram (ECG) or urgent target vessel revascularization (TVR) (including both repeat PCI and coronary artery bypass graft surgery (CABG)
Device success	At discharge of baseline hospitalisation, on average 3 days	Device success (applying a lesion-level analysis)
Major adverse cardiac and cerebral events (MACCE)	1 year	Major adverse cardiac and cerebral events (MACCE) defined as a composite of cardiac death, myocardial infarction, target vessel revascularization and stroke
Target Lesion Failure (TLF)	1 year	Target Lesion Failure (TLF) is defined as cardiac death, myocardial infarction attributed to the target vessel and clinically indicated target lesion revascularization
Major or clinically relevant non-major bleeding (MCB)	1 year	Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events

Trial Locations

Locations (11)

Rijnstate ziekenhuis; 🇳🇱 Arnhem, Netherlands

Meander ziekenhuis; 🇳🇱 Amersfoort, Netherlands

Tergooi ziekenhuis Blaricum; 🇳🇱 Blaricum, Netherlands

Maasstadziekenhuis; 🇳🇱 Rotterdam, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

MCL Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Albert Schweitzer ziekenhuis; 🇳🇱 Dordrecht, Netherlands

Ziekenhuis Zorgsaam; 🇳🇱 Terneuzen, Netherlands

St.Antonius ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Catherina ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Jeroen Bosch ziekenhuis; 🇳🇱 's-Hertogenbosch, Netherlands