CRUZ Tunisia-Multivessel Registry
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
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 design
Treatments tested in this trial
- Supraflex Cruz Sirolimus-eluting Coronary Stent System
Treatment groups
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov