A prospective multicenter randomized post market all-comer trial to assess the safety and effectiveness of the SUPRAFLEX sirolimus-eluting coronary stent system for the treatment of atherosclerotic lesion(s).

Phase 4

Completed

• Conditions: Stenosis of one or more of the vessels of the heart/ Cardio vascular stenosis; 10011082

• Registration Number: NL-OMON45959
• Lead Sponsor: Cardialysis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

1. Male or female patients >=18 years;
2. Presence of one or more coronary artery stenoses of >=50% in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
3. The vessel should have a reference vessel diameter ranging from >=2.25 mm to <=4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length)

Exclusion Criteria

1. Known pregnancy or breastfeeding at time of randomization;
2. Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
3. Any PCI treatment within 6 months (<6 months) prior to the index procedure.
4. Concurrent medical condition with a life expectancy of less than 12 months.
5. The patient is unwilling/not able to return for outpatient clinic at 1 month and 12 months follow-up.
6. Currently participating in another trial and not yet at its primary endpoint.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for this trial is a non-inferiority comparison of the<br /><br>device-oriented composite endpoint Target Lesion Failure of the SUPRAFLEX group<br /><br>to the XIENCE group at 12 months post-procedure. TLF (DoCE) is a composite of<br /><br>clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI)<br /><br>and clinically-indicated target lesion revascularization (TLR).</p><br>