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

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).

Study Overview

• Status: Recruiting
• Conditions: Patient Population With Multivessel Disease
• Intervention / Treatment: Device: Supraflex Cruz Sirolimus-eluting Coronary Stent System

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

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Prof. Nadhem HAJLAOUI; Phone Number: +216 55130873; Email: drnadhemhajlaoui@gmail.com

Study Locations

• Tunisia
  • Sousse, Tunisia, 4054
    • Recruiting
    • Sahloul Hospital
    • Sub-Investigator: Pr. Neffati Elyes
  • Tunis, Tunisia, 1089
    • Recruiting
    • Habib Thameur Hospital
    • Sub-Investigator: Pr. Kraiem Sondess

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient population with multivessel disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient population with multivessel disease; Supraflex Cruz Sirolimus-eluting Coronary Stent System	Device: Supraflex Cruz Sirolimus-eluting Coronary Stent System; Biodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	TLF is defined as: "a composite endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR)".	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)		30 days, 6 months
All-cause mortality		30 days, 6 months, and 12 months
Any myocardial infarction (MI), includes non-target vessel territory		30 days, 6 months, and 12 months
Any revascularization		30 days, 6 months, and 12 months
Definite/probable stent thrombosis		30 days, 6 months, and 12 months
Target Vessel Failure (TVF)	TVF is defined as: "a composite endpoint of cardiovascular death, target vessel myocardial infarction, or clinically driven target vessel revascularization"	30 days, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Sahajanand Medical Technologies Limited
• Investigators: Principal Investigator: Prof. Nadhem HAJLAOUI, University of Tunis El Manar, Tunisia

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Multivessel disease, Supraflex Cruz, SES
• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Sirolimus
• Other Study ID Numbers: CRUZ/TUNISIA-MV/01-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No