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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Tunisia
Sahloul Hospital
RECRUITING
Sousse
Habib Thameur Hospital
RECRUITING
Tunis
Contact Information
Primary
Prof. Nadhem HAJLAOUI
drnadhemhajlaoui@gmail.com
+216 55130873
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2028-05
Participants
Target number of participants: 1000
Treatments
Patient population with multivessel disease
Supraflex Cruz Sirolimus-eluting Coronary Stent System
Related Therapeutic Areas
Sponsors
Leads: Sahajanand Medical Technologies Limited

This content was sourced from clinicaltrials.gov