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

• ClinicalTrials.gov Identifier: NCT04612179
• Recruitment Status: Recruiting
• First Posted: November 2, 2020
• Last Update Posted: July 2, 2021
• Sponsor: IHF GmbH - Institut für Herzinfarktforschung
• Information provided by (Responsible Party): IHF GmbH - Institut für Herzinfarktforschung

Study Description

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.

Condition or disease	Intervention/treatment
Coronary Disease	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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 12 Months
• Official Title: 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
• Actual Study Start Date: June 23, 2021
• Estimated Primary Completion Date: October 1, 2023
• Estimated Study Completion Date: March 30, 2024

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Device Oriented Composite Endpoint [ Time Frame: 12 month ]
   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)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 80 Years to 99 Years (Older Adult)
• Sexes Eligible for Study: All
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: David M Leistner, Prof.; +49-(30) 450 - 513725; david-manuel.leistner@charite.de

Contact: Sebastian T Diebold, PhD; +49 621 59577 214; diebold@ihf.de

Locations

Germany

Charité Berlin; Recruiting

Berlin, Germany

Contact: Arash Haghikia, MD

Sponsors and Collaborators

IHF GmbH - Institut für Herzinfarktforschung

Investigators

• Principal Investigator: David M Leistner, Prof; Charite University, Berlin, Germany

More Information

• Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
• ClinicalTrials.gov Identifier: NCT04612179
• Other Study ID Numbers: Cruz-Senior
• First Posted: November 2, 2020
• Last Update Posted: July 2, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IHF GmbH - Institut für Herzinfarktforschung:

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

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Sirolimus; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs