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

NCT ID: NCT00598715

Last Updated: 2010-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Coronary Artery Disease

Keywords

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In-stent restenosis In-DES-restenosis paclitaxel sirolimus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Same drug

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

Group Type EXPERIMENTAL

Sirolimus eluting stent

Intervention Type DEVICE

Sirolimus-eluting stent will be implanted

Different drug

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

Group Type ACTIVE_COMPARATOR

Paclitaxel-eluting stent

Intervention Type DEVICE

Paclitaxel-eluting stent will be implanted

Interventions

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Sirolimus eluting stent

Sirolimus-eluting stent will be implanted

Intervention Type DEVICE

Paclitaxel-eluting stent

Paclitaxel-eluting stent will be implanted

Intervention Type DEVICE

Other Intervention Names

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Cypher Taxus

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Deutsches Herzzentrum Muenchen

Principal Investigators

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Adnan Kastrati, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Julinda Mehilli, MD

Role: STUDY_DIRECTOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status

1. Medizinische Klinik, Klinikum rechts der Isar

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15644543 (View on PubMed)

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.

Reference Type RESULT
PMID: 20226618 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24684757 (View on PubMed)

Other Identifiers

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GE IDE No. S02407

Identifier Type: -

Identifier Source: org_study_id