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出境医 / 临床实验 / Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)

Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)

Study Description
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Coroflex® ISAR NEO coronary stent system

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 Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Target Lesion Revascularization (TLR) rate at 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events) [ Time Frame: 12 months ]
    MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.

  2. Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events) [ Time Frame: 12 months ]
  3. Stent thrombosis rates accumulated up to 12 months [ Time Frame: 12 months ]
    Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.

  4. Rate of bleeding complications accumulated up to 12 months [ Time Frame: 12 months ]
    To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.

  5. Technical/procedural success rate [ Time Frame: immediately after procedure ]

Eligibility Criteria
Contacts and Locations
Tracking Information
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
 (submitted: January 17, 2019)
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
 (submitted: January 21, 2019)
  • Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events) [ Time Frame: 12 months ]
    MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.
  • Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events) [ Time Frame: 12 months ]
  • Stent thrombosis rates accumulated up to 12 months [ Time Frame: 12 months ]
    Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.
  • Rate of bleeding complications accumulated up to 12 months [ Time Frame: 12 months ]
    To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.
  • Technical/procedural success rate [ Time Frame: immediately after procedure ]
Original Secondary Outcome Measures
 (submitted: January 17, 2019)
  • Accumulated MACE at 12 months (including intra-hospital events) [ Time Frame: 12 months ]
    MACE consists of all events TLR (Re-PCI, CABG), MI, cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.
  • Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events) [ Time Frame: 12 months ]
  • Stent thrombosis rates accumulated up to 12 months [ Time Frame: 12 months ]
    Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.
  • Bleeding complications accumulated up to 12 months [ Time Frame: 12 months ]
    To assess the bleeding complications the BARC scale (see definitions) will be used.
  • Technical/procedural success rate [ Time Frame: immediately after procedure ]
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
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".

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
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.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 17, 2019)
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

  • All common significant coronary lesions
  • Target lesion length >34mm need to be covered with at least 2 stents
  • Patients eligible for this study must be at least 18 years of age.
  • The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.

Exclusion Criteria:

  • Intolerance to sirolimus and/or probucol
  • Allergy to components of the coating
  • Pregnancy and lactation
  • Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
  • Cardiogenic shock
  • Risk of an intraluminal thrombus
  • Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
  • Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
  • Severe allergy to contrast media
  • Lesions which are untreatable with PCI or other interventional techniques
  • Patients with an ejection fraction of < 30 %
  • Vascular reference diameter < 2.00 mm
  • Treatment of the left stem (first section of the left coronary artery)
  • Indication for a bypass surgery
  • Contraindication for whichever accompanying medication is necessary
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Matthias Waliszewski +49 30 568207171 Matthias.Waliszewski@bbraun.com
Contact: Denny Herberger +49 30 568207104 Denny.Herberger@bbraun.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party B. Braun Melsungen AG
Study Sponsor B. Braun Melsungen AG
Collaborators Not Provided
Investigators
Principal Investigator: Rene Koning, MD Clinique St. Hilaire
PRS Account B. Braun Melsungen AG
Verification Date September 2020