Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03809715
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

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.

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 : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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".

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809715


Contacts
Layout table for location contacts
Contact: Matthias Waliszewski +49 30 568207171 Matthias.Waliszewski@bbraun.com
Contact: Denny Herberger +49 30 568207104 Denny.Herberger@bbraun.com

Locations
Layout table for location information
France
Clinique St. Hilaire Recruiting
Rouen, France, 76000
Contact: Rene Koning, MD    +33 235 086620    rkoning@clinique-sainthilaire.fr   
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Layout table for investigator information
Principal Investigator: Rene Koning, MD Clinique St. Hilaire

Layout table for additonal information
Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT03809715     History of Changes
Other Study ID Numbers: AAG-O-H-1803
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases