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

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612179
• Other study ID #: Cruz-Senior
• Status: Recruiting
• Start date: June 23, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2023
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: David M Leistner, Prof.
• Phone: +49-(30) 450 - 513725
• Email: david-manuel.leistner[@]charite.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Germany	Charité Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All death	All death, cardiovascular death and non-cardiovascular death rate	6 and 12 month
Secondary	All MI rate	All MI rate at 6 months and 12 months	6 and 12 month
Secondary	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
Secondary	Clinically indicated TLR	Clinically indicated TLR rate at 6 months and 12 months.	6 and 12 month
Secondary	All TLR rate	All TLR rate at 6 months and at 12 months.	6 months and at 12 months.
Secondary	Target Vessel Revascularization (TVR	All Target Vessel Revascularization (TVR) rate at 6 months and at 12 months.	6 months and at 12 months.
Secondary	revascularization rate	All revascularization rate at 6 months and at 12 months.	6 months and at 12 months.
Secondary	Stent Thrombosis	Stent Thrombosis rate at 6 months and at 12 months (ARC2).	6 months and at 12 months
Secondary	Device success	Device success defined as deployment of the stents without system failure or device-related complication	12 month
Secondary	Lesion success	Lesion success defined as the attainment of < 50 % residual stenosis of the target le-sions post-PCI.	12 month
Secondary	Procedure success	Procedure success defined as all lesion successfully treated without the occurrence of DOCE during the hospital stay.	12 month
Secondary	Major Bleeding	Major Bleeding (BARC 3 to 5).	12 month
Secondary	SAQ	Seattle Angina Questionnaire (SAQ) at 6 months	6 months
Secondary	Quality of life PROMIS	Quality of life at 6- and 12-months as measured by PROMIS-29 questionnaire	6- and 12-months
Secondary	Geriatric Assessment - Bartel Index	Geriatric Assessment Questionnaire: Barthel-Index	baseline
Secondary	Geriatric Assessment - Times up and Go Test	Geriatric Assessment Questionnaire: Timed up - and Go Test	baseline
Secondary	Geriatric Assessment - Minimal Mental Status Test	Geriatric Assessment Questionnaire: Minimal Mental Status Test	baseline
Secondary	Geriatric Assessment - G8 Questionnaire	Geriatric Assessment Questionnaire: G8 Questionnaire	baseline
Secondary	Geriatric Assessment - General Living conditions	Geriatric Assessment Questionnaire: general living condition	baseline