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Completed

NCT Number: NCT03809715

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

The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique St. Hilaire

Rouen, 76000, France

About this study

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.

Who can participate

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

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

Treatment and study plan

Coroflex® ISAR NEO coronary stent system

Device

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 outcomes

  1. Target Lesion Revascularization (TLR) rate at 12 months

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jan 18, 2019
Registry last updated
Jan 8, 2026

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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