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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00987324
First received: August 27, 2009
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Heart Disease
Ischemia
Restenosis
Device: Taxus stent
Device: SeQuent Please
Device: Conventional Balloon Catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Percent in-segment diameter stenosis at follow-up angiography [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-segment minimal luminal diameter [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
  • In-segment binary angiographic restenosis [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
  • Combined incidence of death or myocardial infarction [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]
  • Incidence of thrombosis [ Time Frame: 1 and 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 402
Study Start Date: July 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987324

Locations
Germany
1. Med. Klinik, Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Herz-Zentrum
Bad Krozingen, Germany, 79189
Deutsches Herzzentrum
Munich, Germany, 80636
Sponsors and Collaborators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00987324     History of Changes
Other Study ID Numbers: GE IDE NO. S02908
Study First Received: August 27, 2009
Last Updated: January 3, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Additional relevant MeSH terms:
Heart Diseases
Ischemia
Cardiovascular Diseases
Pathologic Processes
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014