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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient population with multivessel disease | Supraflex Cruz Sirolimus-eluting Coronary Stent System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraflex Cruz Sirolimus-eluting Coronary Stent System | Device | Biodegradable polymer-coated, cobalt-chromium sirolimus-eluting coronary stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | TLF is defined as: "a composite endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR)". | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | 30 days, 6 months | |
| All-cause mortality | 30 days, 6 months, and 12 months | |
| Any myocardial infarction (MI), includes non-target vessel territory |
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Inclusion Criteria:
Exclusion Criteria:
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Patient population with multivessel disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Nadhem HAJLAOUI | Contact | +216 55130873 | drnadhemhajlaoui@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Nadhem HAJLAOUI | University of Tunis El Manar, Tunisia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahloul Hospital | Recruiting | Sousse | 4054 | Tunisia |
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| 30 days, 6 months, and 12 months |
| Any revascularization | 30 days, 6 months, and 12 months |
| Definite/probable stent thrombosis | 30 days, 6 months, and 12 months |
| Target Vessel Failure (TVF) | TVF is defined as: "a composite endpoint of cardiovascular death, target vessel myocardial infarction, or clinically driven target vessel revascularization" | 30 days, 6 months, and 12 months |
| Habib Thameur Hospital | Recruiting | Tunis | 1089 | Tunisia |
|