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

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. Identifier: NCT00987324
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : November 21, 2016
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

August 27, 2009
September 30, 2009
November 21, 2016
July 2009
July 2012   (Final data collection date for primary outcome measure)
Percent in-segment diameter stenosis at follow-up angiography [ Time Frame: 6-8 months ]
Same as current
Complete list of historical versions of study NCT00987324 on Archive Site
  • In-segment minimal luminal diameter [ Time Frame: 6-8 months ]
  • In-segment binary angiographic restenosis [ Time Frame: 6-8 months ]
  • Combined incidence of death or myocardial infarction [ Time Frame: 1 and 2 years ]
  • Incidence of thrombosis [ Time Frame: 1 and 2 years ]
Same as current
Not Provided
Not Provided
Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis
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).

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Disease
  • Ischemia
  • Restenosis
  • Device: Taxus stent
    Implantation of paclitaxel-eluting stent
  • Device: SeQuent Please
    Dilation with SeQuent Please (paclitaxel-eluting balloon)
  • Device: Conventional Balloon Catheter
    Ryuijin, Trek
  • Experimental: Paclitaxel-eluting stent
    Paclitaxel-eluting stent (Taxus)
    Intervention: Device: Taxus stent
  • Active Comparator: Plain Balloon
    plain balloon angioplasty
    Intervention: Device: Conventional Balloon Catheter
  • Experimental: Paclitaxel-eluting balloon
    SeQuent Please
    Intervention: Device: SeQuent Please

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2013
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
GE IDE NO. S02908
Not Provided
Not Provided
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Not Provided
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Munich
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum
Study Director: Klaus Tiroch, MD Deutsches Herzzentrum
Deutsches Herzzentrum Muenchen
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP