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

NCT00598715 | Completed Phase 4 DMC

• 1 other identifier: GE IDE No. S02407
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronary Artery Disease

Keywords

In-stent restenosis; In-DES-restenosis; paclitaxel; sirolimus

Outcome Measures

Primary Outcomes (1)

• Late luminal loss at follow-up angiography

  6-8 months

Secondary Outcomes (4)

• Need of target lesion revascularization.

  12 months

• Combined incidence of death or myocardial infarction.

  12 months

• Incidence of stent thrombosis.

  12 months

• Incidence of binary restenosis at follow-up angiography

  6-8 months

Study Arms (2)

Same drug

EXPERIMENTAL

sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent

Device: Sirolimus eluting stent

Different drug

ACTIVE COMPARATOR

paclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent

Device: Paclitaxel-eluting stent

Interventions

Sirolimus eluting stent DEVICE

Sirolimus-eluting stent will be implanted

Also known as: Cypher

Same drug

Paclitaxel-eluting stent DEVICE

Paclitaxel-eluting stent will be implanted

Also known as: Taxus

Different drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (2)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

1. Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Related Publications (3)

• Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig 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. doi: 10.1001/jama.293.2.165.

  PMID: 15644543 BACKGROUND

• Mehilli J, Byrne RA, Tiroch K, Pinieck S, Schulz S, Kufner S, Massberg S, Laugwitz KL, Schomig A, Kastrati A; ISAR-DESIRE 2 Investigators. Randomized trial of paclitaxel- versus sirolimus-eluting stents for treatment of coronary restenosis in sirolimus-eluting stents: the ISAR-DESIRE 2 (Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2) study. J Am Coll Cardiol. 2010 Jun 15;55(24):2710-6. doi: 10.1016/j.jacc.2010.02.009. Epub 2010 Mar 11.

  PMID: 20226618 RESULT

• Kufner S, Byrne RA, de Waha A, Schulz S, Joner M, Laugwitz KL, Kastrati A; Intracoronary Stenting and Angiographic Results: Drug Eluting Stents for In-Stent Restenosis 2, (ISAR-DESIRE 2) Investigators. Sirolimus-eluting versus paclitaxel-eluting stents in diabetic and non-diabetic patients within sirolimus-eluting stent restenosis: results from the ISAR-DESIRE 2 trial. Cardiovasc Revasc Med. 2014 Mar;15(2):69-75. doi: 10.1016/j.carrev.2014.02.001. Epub 2014 Feb 15.

  PMID: 24684757 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

• Julinda Mehilli, MD

  Deutsches Herzzentrum Muenchen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 22, 2008
• Study Start: October 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 17, 2010

Record last verified: 2009-09

Locations

DE (2)