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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Disease
• Intervention / Treatment: Device: The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system

Detailed Description

This is a prospective, multicentre, open-label, single-armed, non-interventional observa-tional clinical investigation in aged patients (≥80 years) undergoing PCI using at least one Supraflex sirolimus eluting stent as per current practice. The registry is an observational study and patient's participation in this study has no impact on his or her indication for treatment, diagnostics, or therapy. Subjects are supposed to be treated according to cur-rent guidelines and the site's internal directives.

Inclusion in the registry is completely independent of the medical treatment. All products used for the medical treatment should be administered as stated in their SmPCs (Sum-mary of Product Characteristics) and/or Instructions for Use (IFU). Treatment pattern and treatment initiation, continuation, or changes are solely at the discretion of the physician and the patient. There will be no attempt to influence the treatment patterns of any indi-vidual treating physician. All drug subscriptions applied will be in the usual standard of care. Participation in the registry will in no way influence payment or reimbursement for any treatment received by subjects during the study.

The study will be conducted about 37 sites in Germany, Switzerland and Austria and 2000 subjects will be included. A total study duration of about 39 months is assumed, of which about 18 months account for enrolment and 12 months for the follow-up.

Eligible are all patients with chronic- (CCS) or acute- Non-ST-elevation coronary syndrome (NSTE-ACS) and target lesion suitable for PCI with drug-eluting stent (see section 6.3 for detailed eligibility criteria) undergoing PCI using at least one SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system as per current practice, who will visit consecutively a partici-pating investigation site. It is planned to enroll about 2000 patients in total.

Following discharge, patients will be treated according to clinical routine/guidelines. Hence, no study-specific pre-planned procedures will be performed.

To assess the primary endpoint, all patients will receive telephone calls at 6 and 12 months following index procedure and will be interviewed by means of a standardized patient interview by the investigation sites.

On-site monitoring will be performed (about 1.5 visits per site; risk-based approach). Dur-ing on-site monitoring, the monitor will verify patient informed consent documentation and perform source data verification against the patient's medical records. In addition, an attempt will be made to check the consecutiveness of patient enrolment at the site, fully respecting privacy and personal data of subjects who are not enrolled in the registry and consequently have not given informed consent.

Data will be captured at three time points:

• Baseline (e.g. site and patient characteristics, index procedure, events, etc.),
• 6-months FU (e.g. vital status, endpoint-related events, quality of life, adverse events, etc.) and
• 12-months FU (e.g. vital status, endpoint-related events, quality of life, adverse events, etc.)

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: David M Leistner, Prof.; Phone Number: +49-(30) 450 - 513725; Email: david-manuel.leistner@charite.de
• Study Contact Backup: Name: Sebastian T Diebold, PhD; Phone Number: +49 621 59577 214; Email: diebold@ihf.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Charite Berlin
    • Contact: Arash Haghikia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years to 99 years (Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Written consent received from the patient or a legal repre-sentative after the information has been provided.
2. ≥ 80 years of age.
3. De-novo or re-stenotic significant stenosis in at least one cor-onary vessel.
4. 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).
5. Target lesion suitable for PCI with SUPRAFLEX CRUZ™ Siroli-mus eluting coronary stent system with diameter between 2.0 and 4.5 mm
6. Total lesion length should be from 6-120 mm

Exclusion Criteria:

1. Patients with ST-elevation myocardial infarction (STE-ACS)
2. Hemodynamic instability or cardiogenic shock
3. 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
4. Any co-morbid condition with life expectancy < 1 year or that may result in protocol non-compliance
5. Patients who are participating in another drug or device inves-tigational study, which has not reached its primary endpoint
6. Patients under judicial protection, tutorship or curatorship

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All death	All death, cardiovascular death and non-cardiovascular death rate	6 and 12 month
All MI rate	All MI rate at 6 months and 12 months	6 and 12 month
Rate of TV-MI and MI not	Rate of TV-MI and MI not clearly attributable to non-target vessel at 6 months and at 12 months	6 and 12 month
Clinically indicated TLR	Clinically indicated TLR rate at 6 months and 12 months.	6 and 12 month
All TLR rate	All TLR rate at 6 months and at 12 months.	6 months and at 12 months.
Target Vessel Revascularization (TVR	All Target Vessel Revascularization (TVR) rate at 6 months and at 12 months.	6 months and at 12 months.
revascularization rate	All revascularization rate at 6 months and at 12 months.	6 months and at 12 months.
Stent Thrombosis	Stent Thrombosis rate at 6 months and at 12 months (ARC2).	6 months and at 12 months
Device success	Device success defined as deployment of the stents without system failure or device-related complication	12 month
Lesion success	Lesion success defined as the attainment of < 50 % residual stenosis of the target le-sions post-PCI.	12 month
Procedure success	Procedure success defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay.	12 month
Major Bleeding	Major Bleeding (BARC 3 to 5).	12 month
SAQ	Seattle Angina Questionnaire (SAQ) at 6 months	6 months
Quality of life PROMIS	Quality of life at 6- and 12-months as measured by PROMIS-29 questionnaire	6- and 12-months
Geriatric Assessment - Bartel Index	Geriatric Assessment Questionnaire: Barthel-Index	baseline
Geriatric Assessment - Times up and Go Test	Geriatric Assessment Questionnaire: Timed up - and Go Test	baseline
Geriatric Assessment - Minimal Mental Status Test	Geriatric Assessment Questionnaire: Minimal Mental Status Test	baseline
Geriatric Assessment - G8 Questionnaire	Geriatric Assessment Questionnaire: G8 Questionnaire	baseline
Geriatric Assessment - General Living conditions	Geriatric Assessment Questionnaire: general living condition	baseline

Collaborators and Investigators

• Sponsor: IHF GmbH - Institut für Herzinfarktforschung
• Investigators: Principal Investigator: David M Leistner, Prof, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: PCI; CAD; Cruz Stent; CCS; NSTE-ACS
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: Cruz-Senior

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No