Clinical trial NCT06663696: CRUZ Tunisia-Multivessel Registry
Official title: Evaluation of the Safety and Clinical Performance of the Biodegradable Polymer-Coated Sirolimus-Eluting Stent in All-Comer Patients With Multivessel Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient Population With Multivessel Disease
Keywords: Multivessel disease, Supraflex Cruz, SES
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population with multivessel disease

Brief 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).

Detailed description: This is a prospective, observational, single-arm, multi-center, registry designed to evaluate the safety and clinical performance of the Supraflex Cruz SES in an unselected, all-comer patient population with multivessel disease. The multivessel disease, defined as the presence of two or more vessels that will be exclusively treated with the Supraflex Cruz SES. The registry aims to reflect daily clinical practice including, but not limited to patients with chronic coronary artery disease (CAD) as well as acute coronary syndrome (STEMI and NSTEMI).

All patients will be followed as per routine clinical practice together with either telephonic or clinical follow-up at 30 days, 6 months, and 12 months after the index procedure.

Subgroups are pre-specified for post-hoc exploratory analyses with respect to the primary endpoint of Target Lesion Failure (TLF) at 12 months. The following subgroups are pre-defined according to their presentation at enrolment:

1. Treatment in relation to clinical presentation \[Acute Coronary Syndrome (ACS)\]
2. Treatment in relation to specific lesion subsets \[Left Main, Chronic Total Occlusion\]
3. Patients undergoing atherectomy

Eligibility criteria: 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

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 30 days, 6 months
measure: All-cause mortality
timeFrame: 30 days, 6 months, and 12 months
measure: Any myocardial infarction (MI), includes non-target vessel territory
timeFrame: 30 days, 6 months, and 12 months
measure: Any revascularization
timeFrame: 30 days, 6 months, and 12 months
measure: Definite/probable stent thrombosis
timeFrame: 30 days, 6 months, and 12 months
measure: Target Vessel Failure (TVF)
timeFrame: 30 days, 6 months, and 12 months
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Sahloul Hospital
city: Tunis
country: Tunisia
facility: Habib Thameur Hospital
Study officials:
affiliation: University of Tunis El Manar, Tunisia
name: Prof. Nadhem HAJLAOUI
role: PRINCIPAL_INVESTIGATOR
References: