Coroflex ISAR 2000 Extended Registry (ISAR2000 Extended)

February 7, 2022 updated by: B. Braun Melsungen AG

Coroflex ISAR 2000 Extended Postmarket Surveillance Non-Interventional Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité University Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Pusat Perubatan Universiti Malaya
  • Spain
      • Ciudad Real, Spain, 13005
        • Hospital General Universitario De Ciudad Real

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Unselected patients with coronary de-novo and/or restenotic lesions

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinically driven Target Lesion Revascularization
Time Frame: 9 months
re-intervention of the target lesion
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events
Time Frame: 9 months
MACE=TLR+MI+cardiac/unknown death
9 months
Myocardial infarction rate
Time Frame: 9 months
myocardial infarction
9 months
Cardiac death rate
Time Frame: 9 months
cardiac death including death of unknown causes
9 months
Target lesion revascularization rate
Time Frame: 9 months
TLR=CABG + Re-PCI
9 months
Procedural success
Time Frame: immediately after stent implantation (within the first 30 minutes)
Success rate to cross and treat the coronary lesion
immediately after stent implantation (within the first 30 minutes)
Stent thrombosis rates
Time Frame: 0-9 months
acute, subacute and 9-month stent thrombosis rates
0-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Collaborators

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Florian Krackhardt, MD, Charité Virchow Unversity Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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