Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04612179
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2020-10-30
Brief 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
Sponsor:
IHF GmbH - Institut für Herzinfarktforschung
Organization:
IHF GmbH - Institut für Herzinfarktforschung
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 sites 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 andor 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 63 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 routineguidelines 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 15 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 patients 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 eg site and patient characteristics index procedure events etc
6-months FU eg vital status endpoint-related events quality of life adverse events etc and
12-months FU eg vital status endpoint-related events quality of life adverse events etc
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 andor 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 63 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 routineguidelines 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 15 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 patients 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 eg site and patient characteristics index procedure events etc
6-months FU eg vital status endpoint-related events quality of life adverse events etc and
12-months FU eg vital status endpoint-related events quality of life adverse events etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None