Health Trials

CRUZ Tunisia-Multivessel Registry

ConditionPatient Population With Multivessel Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorSahajanand Medical Technologies Limited

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patient population with multivessel disease

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Supraflex Cruz Sirolimus-eluting Coronary Stent System

    Device

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

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Patient population with multivessel disease1 intervention

Trial outcomes

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)".

Time frame
12 months

Secondary outcomes

1

Target Lesion Failure (TLF)

Time frame
30 days, 6 months
2

All-cause mortality

Time frame
30 days, 6 months, and 12 months
3

Any myocardial infarction (MI), includes non-target vessel territory

Time frame
30 days, 6 months, and 12 months
4

Any revascularization

Time frame
30 days, 6 months, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahajanand Medical Technologies Limited

Lead sponsor

Source ClinicalTrials.gov
Apply now