Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents

Coronary Artery Disease Clinical Trial

— DESIRE-2  

Official title:

Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598715
• Other study ID #: GE IDE No. S02407
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2008
• Last updated: December 16, 2010
• Start date: October 2007
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• 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

For lesions which develop restenosis after a drug-eluting stent, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug.

Description:

Treatment of in-stent restenosis after implantation of a DES has poorly been studied. Although there are no data, it may be assumed that certain lesions might be resistant to a given drug and in need of a different DES. Thus, for lesions which develop restenosis after a DES, it is not known which the right strategy to use is, implantation of the same type of DES as the initial one or a DES with a different drug. This prospective, randomized trial will compare the anti-restenotic efficacy of PES or SES in patients with restenosis after initial implantation of a SES

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of > 50% re- stenosis after prior implantation of Sirolimus eluting stents 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:

• Cardiogenic shock

• Acute myocardial infarction within the first 48 hours from symptom onset.

• Target lesion located in the left main trunk or bypass graft.

• 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.

• Allergy to antiplatelet therapy, sirolimus, paclitaxel, stainless steel.

• Pregnancy (present, suspected or planned) or positive pregnancy test.

• Previous enrollment in this trial.

• Patient's inability to fully comply with the study protocol.

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Sirolimus eluting stent
Sirolimus-eluting stent will be implanted
• Paclitaxel-eluting stent
Paclitaxel-eluting stent will be implanted

Locations

Country	Name	City	State
Germany	1. Medizinische Klinik, Klinikum rechts der Isar	Munich
Germany	Deutsches Herzzentrum Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schühlen H, Schmitt C, Dirschinger J, Schömig A; ISAR-DESIRE Study Investigators. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005 Jan 12;293(2):165-71. — View Citation

Mehilli J, Byrne RA, Tiroch K, Pinieck S, Schulz S, Kufner S, Massberg S, Laugwitz KL, Schömig A, Kastrati A; ISAR-DESIRE 2 Investigators. Randomized trial of paclitaxel- versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-el — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late luminal loss at follow-up angiography		6-8 months	No
Secondary	Need of target lesion revascularization.		12 months	No
Secondary	Combined incidence of death or myocardial infarction.		12 months	Yes
Secondary	Incidence of stent thrombosis.		12 months	Yes
Secondary	Incidence of binary restenosis at follow-up angiography		6-8 months	No