Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis (ISAR-DESIRE-3)
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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 |
- Percent in-segment diameter stenosis at follow-up angiography [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
- Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
- In women with childbearing potential a negative pregnancy test is mandatory.
Exclusion Criteria:
- Age < 18 years.
- Cardiogenic shock.
- Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
- Target lesion located in the left main trunk or bypass graft.
- Target lesion located in small vessel (vessel size < 2.0 mm).
- 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.
- Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min).
- Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome.
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Previous enrollment in this trial.
- Patient's inability to fully comply with the study protocol.
Contacts and Locations| Germany | |
| 1. Med. Klinik, Klinikum rechts der Isar | |
| Munich, Bavaria, Germany, 81675 | |
| Herz-Zentrum | |
| Bad Krozingen, Germany, 79189 | |
| Deutsches Herzzentrum | |
| Munich, Germany, 80636 | |
| 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 May 21, 2013