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RecruitingNCT06663696

CRUZ Tunisia-Multivessel Registry

Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease

Sponsor

Sahajanand Medical Technologies Limited

Enrollment

1,000 participants

Start Date

Nov 1, 2024

Study Type

OBSERVATIONAL

Conditions

Patient Population With Multivessel Disease

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

DEVICESupraflex Cruz Sirolimus-eluting Coronary Stent System

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

Locations(2)

Sahloul Hospital

Sousse, Tunisia

Habib Thameur Hospital

Tunis, Tunisia

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NCT06663696