CRUZ Tunisia-Multivessel Registry

NCT06663696 | Recruiting

• 1 other identifier: CRUZ/TUNISIA-MV/01-2023
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Patient Population With Multivessel Disease

Keywords

Multivessel disease, Supraflex Cruz, SES

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Patient population with multivessel disease

Supraflex Cruz Sirolimus-eluting Coronary Stent System

Device: Supraflex Cruz Sirolimus-eluting Coronary Stent System

Interventions

Supraflex Cruz Sirolimus-eluting Coronary Stent System DEVICE

Biodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent

Patient population with multivessel disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient population with multivessel disease

You may qualify if:

• Patient must be at least 18 years of age
• 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
• 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
• The patient is willing and able to co-operate with study procedures and required follow up visits

You may not qualify if:

• Women with known pregnancy or who are lactating
• High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)
• Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
• 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

Sponsors & Collaborators

• Sahajanand Medical Technologies Limited: lead

Study Sites (2)

Sahloul Hospital

Sousse, 4054, Tunisia

RECRUITING

Habib Thameur Hospital

Tunis, 1089, Tunisia

RECRUITING

Study Officials

• Prof. Nadhem HAJLAOUI

  University of Tunis El Manar, Tunisia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Nadhem HAJLAOUI

CONTACT

+216 55130873; drnadhemhajlaoui@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)