Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis (ISAR-DESIRE-3)

November 18, 2016 updated by: Deutsches Herzzentrum Muenchen

Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus.

Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions.

The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in "limus"-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Phase 4

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
      • Bad Krozingen, Germany, 79189
        • Herz-Zentrum
      • Munich, Germany, 80636
        • Deutsches Herzzentrum
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • 1. Med. Klinik, Klinikum rechts der Isar

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

Description

Inclusion Criteria:

  1. Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
  2. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
  3. In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

  1. Age < 18 years.
  2. Cardiogenic shock.
  3. Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
  4. Target lesion located in the left main trunk or bypass graft.
  5. Target lesion located in small vessel (vessel size < 2.0 mm).
  6. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  7. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min).
  8. Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome.
  9. Pregnancy (present, suspected or planned) or positive pregnancy test.
  10. Previous enrollment in this trial.
  11. Patient's inability to fully comply with the study protocol.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel-eluting stent
Paclitaxel-eluting stent (Taxus)
Device: Taxus stent
Implantation of paclitaxel-eluting stent
Active Comparator: Plain Balloon
plain balloon angioplasty
Device: Conventional Balloon Catheter
Ryuijin, Trek
Experimental: Paclitaxel-eluting balloon
SeQuent Please
Device: SeQuent Please
Dilation with SeQuent Please (paclitaxel-eluting balloon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent in-segment diameter stenosis at follow-up angiography
Time Frame: 6-8 months
6-8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
In-segment minimal luminal diameter
Time Frame: 6-8 months
6-8 months
In-segment binary angiographic restenosis
Time Frame: 6-8 months
6-8 months
Combined incidence of death or myocardial infarction
Time Frame: 1 and 2 years
1 and 2 years
Incidence of thrombosis
Time Frame: 1 and 2 years
1 and 2 years

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Principal Investigator: Julinda Mehilli, MD, Deutsches Herzzentrum Munich
  • Study Chair: Adnan Kastrati, MD, Deutsches Herzzentrum
  • Study Director: Klaus Tiroch, MD, Deutsches Herzzentrum

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

July 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 27, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE NO. S02908

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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