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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.
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 CRUZâ„¢ 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The SUPRAFLEX CRUZâ„¢ Sirolimus eluting coronary stent system | Device | Investigational device: SUPRAFLEX CRUZâ„¢ Sirolimus eluting Coronary Stent System The SUPRAFLEX CRUZâ„¢ 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 CRUZâ„¢ Sirolimus eluting coronary stent is Sirolimus (also known as Rapamycin). The SUPRAFLEX CRUZâ„¢ 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| David M Leistner, Prof | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Berlin | Berlin | Germany |
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| 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 |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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