RecruitingNot Applicable

CRUZ Tunisia-Multivessel Registry

Tunisia1,000 participantsStarted 2024-11-01

Plain-language 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).

Who can participate

Age range18 Years – 99 Years

SexALL

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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

What they're measuring

Target Lesion Failure (TLF)

Timeframe: 12 months

Trial details

NCT IDNCT06663696

SponsorSahajanand Medical Technologies Limited

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-11

Contact for this trial

Prof. Nadhem HAJLAOUI

+216 55130873 drnadhemhajlaoui@gmail.com

View on ClinicalTrials.gov More Patient Population With Multivessel Disease trials