Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in the Treatment of an Octo- and Nonagenerian All-Comer Patient Cohort With Coronary Artery Disease - the Cruz Senior Study

NCT04612179 | Completed

• 1 other identifier: Cruz-Senior
• Study Type: observational
• Target: 2,017
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, multi-centre, open-label, single-armed, non-interventional observational clinical investigation designed to enrol 2000 octo- and nonagenerian all-comer patients with coro-nary artery disease in up to 37 sites in Germany, Switzerland and Austria. Patients underwent PCI using at least one Supraflex Cruz Sirolimus Eluting stent as per current practice and will be followed up for 12 months.

Conditions

Coronary Disease

Keywords

CAD; PCI; Cruz Stent; CCS; NSTE-ACS

Outcome Measures

Primary Outcomes (1)

• Device Oriented Composite Endpoint

  Device Oriented Composite Endpoint (DOCE as per ARC2) at 12 months defined as compo-site of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (TLR)

  12 month

Secondary Outcomes (19)

• All death

  6 and 12 month

• All MI rate

  6 and 12 month

• Rate of TV-MI and MI not

  6 and 12 month

• Clinically indicated TLR

  6 and 12 month

• All TLR rate

  6 months and at 12 months.

Study Arms (1)

All Comer Patients

All-comer patients (≥80 years) affected by acute coronary syn-drome (NSTE-ACS), stabile angina, or silent angina, who qualify for percutaneous coronary intervention (PCI) according to ESC-treatment guidelines and physicians' clinical routine estimation.

Device: The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system

Interventions

The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system DEVICE

Investigational device: SUPRAFLEX CRUZ™ Sirolimus eluting Coronary Stent System The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system consists of a balloon ex-pandable Sirolimus eluting stent, premounted on a stent delivery system. The active pharmaceutical ingredient in the SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent is Sirolimus (also known as Rapamycin). The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic Ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions in native coronary arter-ies with a reference vessel diameter of 2.00 mm to 4.50 mm.

All Comer Patients

Eligibility Criteria

• Age: 80 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comer patients (≥80 years) affected by acute coronary syn-drome (NSTE-ACS), stabile angina, or silent angina, who qualify for percutaneous coronary intervention (PCI) according to ESC-treatment guidelines and physicians' clinical routine estimation.

You may qualify if:

• Written consent received from the patient or a legal repre-sentative after the information has been provided.
• ≥ 80 years of age.
• De-novo or re-stenotic significant stenosis in at least one cor-onary vessel.
• Patients with NSTE-ACS, unstable angina, stable angina, silent ischemia (no limitation of the number of treated lesions and vessels: planned staged procedures are allowed within 3 months using Supraflex Cruz only).
• Target lesion suitable for PCI with SUPRAFLEX CRUZ™ Siroli-mus eluting coronary stent system with diameter between 2.0 and 4.5 mm
• Total lesion length should be from 6-120 mm

You may not qualify if:

• Patients with ST-elevation myocardial infarction (STE-ACS)
• Hemodynamic instability or cardiogenic shock
• Known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (DAPT) medication required by cur-rent practice
• Any co-morbid condition with life expectancy \< 1 year or that may result in protocol non-compliance
• Patients who are participating in another drug or device inves-tigational study, which has not reached its primary endpoint
• Patients under judicial protection, tutorship or curatorship

Sponsors & Collaborators

• IHF GmbH - Institut für Herzinfarktforschung: lead

Study Sites (1)

Charité Berlin

Berlin, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• David M Leistner, Prof

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 2, 2020
• Study Start: June 23, 2021
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

DE (1)