NCT06663696

CRUZ Tunisia-Multivessel Registry

Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Sahajanand Medical Technologies Limited · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this registry is to evaluate the safety and clinical performance of the biodegradable polymer-coated Supraflex Cruz Sirolimus-eluting Stent (SES) in an unselected, all-comer patient population with multivessel disease. This population represents daily clinical practice and includes patients requiring coronary revascularization with drug-eluting stents (DES).

Detailed description

This is a prospective, observational, single-arm, multi-center, registry designed to evaluate the safety and clinical performance of the Supraflex Cruz SES in an unselected, all-comer patient population with multivessel disease. The multivessel disease, defined as the presence of two or more vessels that will be exclusively treated with the Supraflex Cruz SES. The registry aims to reflect daily clinical practice including, but not limited to patients with chronic coronary artery disease (CAD) as well as acute coronary syndrome (STEMI and NSTEMI). All patients will be followed as per routine clinical practice together with either telephonic or clinical follow-up at 30 days, 6 months, and 12 months after the index procedure. Subgroups are pre-specified for post-hoc exploratory analyses with respect to the primary endpoint of Target Lesion Failure (TLF) at 12 months. The following subgroups are pre-defined according to their presentation at enrolment: 1. Treatment in relation to clinical presentation \[Acute Coronary Syndrome (ACS)\] 2. Treatment in relation to specific lesion subsets \[Left Main, Chronic Total Occlusion\] 3. Patients undergoing atherectomy

Conditions

• Patient Population With Multivessel Disease

Interventions

Type	Name	Description
DEVICE	Supraflex Cruz Sirolimus-eluting Coronary Stent System	Biodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent

Timeline

• Start date: 2024-11-01
• Primary completion: 2027-11-01
• Completion: 2028-05-01
• First posted: 2024-10-29
• Last updated: 2025-02-19

Locations

2 sites across 1 country: Tunisia