CRUZ Tunisia-Multivessel Registry

Sahajanand Medical Technologies

Status: Enrolling

Conditions: Patient Population With Multivessel Disease

Treatments: Device: Supraflex Cruz Sirolimus-eluting Coronary Stent System

Study type: Observational

Funder types: Industry

Identifiers

NCT06663696

CRUZ/TUNISIA-MV/01-2023

Details and patient eligibility

About

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).

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient must be at least 18 years of age
2. Patients with symptomatic coronary artery multivessel disease requiring the implantation of at least two Supraflex Cruz stents into the coronary vasculature during the index procedure
3. The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
4. The patient is willing and able to co-operate with study procedures and required follow up visits

Exclusion criteria

1. Women with known pregnancy or who are lactating
2. High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)
3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
4. Patients has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, sirolimus or contrast media

Trial design

1,000 participants in 1 patient group

Patient population with multivessel disease

Description:

Supraflex Cruz Sirolimus-eluting Coronary Stent System

Treatment:

Device: Supraflex Cruz Sirolimus-eluting Coronary Stent System