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

August 27, 2009
January 3, 2012
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00987324 on ClinicalTrials.gov Archive Site
  • 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 ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
402
September 2014
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00987324
GE IDE NO. S02908
No
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
January 2012

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