Condition or disease | Intervention/treatment |
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Coronary Artery Disease | Device: Coroflex® ISAR NEO coronary stent system |
Study Type : | Observational |
Estimated Enrollment : | 1037 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo |
Actual Study Start Date : | January 17, 2019 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2022 |
Tracking Information | |||||||||
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First Submitted Date | January 17, 2019 | ||||||||
First Posted Date | January 18, 2019 | ||||||||
Last Update Posted Date | September 22, 2020 | ||||||||
Actual Study Start Date | January 17, 2019 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Target Lesion Revascularization (TLR) rate at 12 months [ Time Frame: 12 months ] | ||||||||
Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF) | ||||||||
Official Title | Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo | ||||||||
Brief Summary | The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions. | ||||||||
Detailed Description | Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device. | ||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population |
The investigator of each study site has the responsibility of screening all potential patients and selecting those who fulfil the inclusion criteria of this study protocol. Therefore, at each site a study with similar inclusion criteria cannot be conducted while the recruitment of this study is in progress. Screening will be performed during the physical examination to verify the "patient related enrolment criteria". The second part of the screening procedure will be completed during the diagnostic angiography to verify that the target lesion fulfils all "lesion related enrolment criteria". |
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Condition | Coronary Artery Disease | ||||||||
Intervention | Device: Coroflex® ISAR NEO coronary stent system
treatment of coronary artery disease with Coroflex® ISAR NEO of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts
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Study Groups/Cohorts | Not Provided | ||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
1037 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | June 2022 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria: Coroflex® ISAR NEO is intended to be used for
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | Not Provided | ||||||||
Contacts |
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Listed Location Countries | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03809715 | ||||||||
Other Study ID Numbers | AAG-O-H-1803 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | B. Braun Melsungen AG | ||||||||
Study Sponsor | B. Braun Melsungen AG | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | B. Braun Melsungen AG | ||||||||
Verification Date | September 2020 |