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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

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Heart Disease Ischemia Restenosis Device: Taxus stent Device: SeQuent Please Device: Conventional Balloon Catheter Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents
Study Start Date : July 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

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)

Primary Outcome Measures :
  1. Percent in-segment diameter stenosis at follow-up angiography [ Time Frame: 6-8 months ]

Secondary Outcome Measures :
  1. In-segment minimal luminal diameter [ Time Frame: 6-8 months ]
  2. In-segment binary angiographic restenosis [ Time Frame: 6-8 months ]
  3. Combined incidence of death or myocardial infarction [ Time Frame: 1 and 2 years ]
  4. Incidence of thrombosis [ Time Frame: 1 and 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00987324

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1. Med. Klinik, Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Bad Krozingen, Germany, 79189
Deutsches Herzzentrum
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
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Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Munich
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum
Study Director: Klaus Tiroch, MD Deutsches Herzzentrum

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT00987324    
Other Study ID Numbers: GE IDE NO. S02908
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action