CRUZ Tunisia-Multivessel Registry
Recruiting now
Conditions studied: Patient Population With Multivessel Disease
In brief
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).
Key facts
- Study ID
- NCT06663696
- Run by
- Sahajanand Medical Technologies Limited
- People needed
- 1000
- Starts
- 2024-11-01
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Sahloul Hospital — Sousse, Tunisia (enrolling)
- Habib Thameur Hospital — Tunis, Tunisia (enrolling)
Full record on ClinicalTrials.gov
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