Clinical trial NCT04612179: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: CAD
PCI
Cruz Stent
CCS
NSTE-ACS
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 2017
Sex: ALL
Minimum age (years): 80
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.)

Eligibility 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

Primary outcomes:
measure: Device Oriented Composite Endpoint
timeFrame: 12 month
Secondary outcomes:
measure: All death
timeFrame: 6 and 12 month
measure: All MI rate
timeFrame: 6 and 12 month
measure: Rate of TV-MI and MI not
timeFrame: 6 and 12 month
measure: Clinically indicated TLR
timeFrame: 6 and 12 month
measure: All TLR rate
timeFrame: 6 months and at 12 months.
measure: Target Vessel Revascularization (TVR
timeFrame: 6 months and at 12 months.
measure: revascularization rate
timeFrame: 6 months and at 12 months.
measure: Stent Thrombosis
timeFrame: 6 months and at 12 months
measure: Device success
timeFrame: 12 month
measure: Lesion success
timeFrame: 12 month
measure: Procedure success
timeFrame: 12 month
measure: Major Bleeding
timeFrame: 12 month
measure: SAQ
timeFrame: 6 months
measure: Quality of life PROMIS
timeFrame: 6- and 12-months
measure: Geriatric Assessment - Bartel Index
timeFrame: baseline
measure: Geriatric Assessment - Times up and Go Test
timeFrame: baseline
measure: Geriatric Assessment - Minimal Mental Status Test
timeFrame: baseline
measure: Geriatric Assessment - G8 Questionnaire
timeFrame: baseline
measure: Geriatric Assessment - General Living conditions
timeFrame: baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: David M Leistner, Prof
role: PRINCIPAL_INVESTIGATOR
References: