Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

Heart Disease Clinical Trial

— ISAR-DESIRE-3  

Official title:

Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987324
• Other study ID #: GE IDE NO. S02908
• Status: Completed
• Phase: Phase 4
• First received: August 27, 2009
• Last updated: November 18, 2016
• Start date: July 2009
• Est. completion date: October 2013

Study information

• Verified date: November 2016
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: October 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases
• Ischemia
• Restenosis

Intervention

Device:
• Taxus stent
Implantation of paclitaxel-eluting stent
• SeQuent Please
Dilation with SeQuent Please (paclitaxel-eluting balloon)
• Conventional Balloon Catheter
Ryuijin, Trek

Locations

Country	Name	City	State
Germany	Herz-Zentrum	Bad Krozingen
Germany	1. Med. Klinik, Klinikum rechts der Isar	Munich	Bavaria
Germany	Deutsches Herzzentrum	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent in-segment diameter stenosis at follow-up angiography		6-8 months	No
Secondary	In-segment minimal luminal diameter		6-8 months	No
Secondary	In-segment binary angiographic restenosis		6-8 months	No
Secondary	Combined incidence of death or myocardial infarction		1 and 2 years	Yes
Secondary	Incidence of thrombosis		1 and 2 years	Yes