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Recruiting NCT06663696

CRUZ Tunisia-Multivessel Registry

— Observational Patient Population With Multivessel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supraflex Cruz Sirolimus-eluting Coronary Stent System.
Who it may be relevant to
Registry conditions: Patient Population With Multivessel Disease. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Tunisia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device Supraflex Cruz Sirolimus-eluting Coronary Stent System
    Biodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent

Primary outcome measures

  • Target Lesion Failure (TLF) [Time frame: 12 months]
Secondary outcome measures (6)
  • Target Lesion Failure (TLF) [Time frame: 30 days, 6 months]
  • All-cause mortality [Time frame: 30 days, 6 months, and 12 months]
  • Any myocardial infarction (MI), includes non-target vessel territory [Time frame: 30 days, 6 months, and 12 months]
  • Any revascularization [Time frame: 30 days, 6 months, and 12 months]
  • Definite/probable stent thrombosis [Time frame: 30 days, 6 months, and 12 months]
  • Target Vessel Failure (TVF) [Time frame: 30 days, 6 months, and 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Tunisia · 2 centers
  • Sahloul Hospital — Sousse
  • Habib Thameur Hospital — Tunis

Identifiers

NCT: NCT06663696 · CRUZ/TUNISIA-MV/01-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗