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Completed

NCT Number: NCT02905214

Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité University Hospital, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stenting with the Coroflex ISAR sirolimus-eluting stent

Device

coronary stenting

Other names: Coroflex ISAR

Primary outcomes

  1. clinically driven Target Lesion Revascularization

    Time frame: 9 months

    re-intervention of the target lesion

Secondary outcomes

  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

    acute, subacute and 9-month stent thrombosis rates

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Collaborators

  • Charite University, Berlin, Germany

Registry information

Official study title

Coroflex ISAR 2000 Extended Postmarket Surveillance Non-Interventional Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Sep 19, 2016
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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