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Coroflex ISAR 2000 Registry (ISAR2000)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02629575
Recruitment Status : Completed
First Posted : December 14, 2015
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
B. Braun Melsungen AG

Study Description
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Brief Summary:
Postmarket surveillance in terms of the safety and efficacy of Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" patients with de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries

Condition or disease Intervention/treatment
Coronary Artery Disease (CAD) Device: stenting with the Coroflex ISAR sirolimus-eluting stent

Detailed Description:
The aim of the study is to assess the safety and efficacy of elective deployment of the Sirolimus-eluting Coroflex ISAR Stent for the treatment of "real world" de-novo and restenotic lesions after stand-alone angioplasty in coronary arteries of 2.0 mm up to 4.0 mm in diameter and up to 30 mm in length for procedural success and preservation of vessel patency.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 2877 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Coroflex ISAR 2000 Postmarket Surveillance Non-Interventional Study
Study Start Date : January 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Groups and Cohorts
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Intervention Details:
  • Device: stenting with the Coroflex ISAR sirolimus-eluting stent
    coronary stenting
    Other Name: Coroflex ISAR

Outcome Measures
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Primary Outcome Measures :
  1. clinically driven Target Lesion Revascularization [ Time Frame: 9 months ]
    re-intervention of the target lesion


Secondary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 9 months ]
    MACE=TLR+MI+cardiac/unknown death

  2. Myocardial infarction rate [ Time Frame: 9 months ]
    myocardial infarction

  3. Cardiac death rate [ Time Frame: 9 months ]
    cardiac death including death of unknown causes

  4. Target lesion revascularization rate [ Time Frame: 9 months ]
    TLR=CABG + Re-PCI

  5. Procedural success [ Time Frame: immediately after stent implantation (within the first 30 minutes) ]
    Success rate to cross and treat the coronary lesion

  6. Stent thrombosis rates [ Time Frame: 0-9 months ]
    rates of acute, subacute and 9-month stent thrombosis rates


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Unselected patients with coronary de-novo and/or restenotic lesions
Criteria

Inclusion Criteria:

  • patients suitable for percutaneous coronary intervention with proof of ischemia
  • at least 18 years of age

Exclusion Criteria:

  • Intolerance to sirolimus and/or probucol
  • Allergy to components of the coating
  • Pregnancy and lactation
  • Complete occlusion of the treatment vessel
  • Severely calcified stenosis
  • Cardiogenic shock
  • Risk of an intraluminal thrombus
  • Haemorrhagic 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 PTCA 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
Contacts and Locations
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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): NCT02629575


Locations
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Germany
Charité University Hospital
Berlin, Germany, 13353
Malaysia
Pusat Perubatan Universiti Malaya
Kuala Lumpur, Malaysia, 59100
Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain, 13005
Sponsors and Collaborators
B. Braun Melsungen AG
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Florian Krackhardt, Dr Charité Virchow Unversity Hospital
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT02629575    
Other Study ID Numbers: AAG-O-H-1408
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
 Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs