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CRUZ Tunisia-Multivessel Registry

RECRUITINGSponsored by Sahajanand Medical Technologies Limited
Actively Recruiting
SponsorSahajanand Medical Technologies Limited
Started2024-11-01
Est. completion2027-11
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted

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).

Eligibility

Age: 18 Years – 99 YearsHealthy volunteers accepted
Inclusion Criteria:

1. Patient must be at least 18 years of age
2. 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
3. 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
4. The patient is willing and able to co-operate with study procedures and required follow up visits

Exclusion Criteria:

1. Women with known pregnancy or who are lactating
2. High probability of non-adherence to the follow-up requirements (due to social, psychological, or medical reasons)
3. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
4. 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

Conditions2

Heart DiseasePatient Population With Multivessel Disease

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