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Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents (DESIRE-2)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Sirolimus eluting stent
Paclitaxel-eluting stent
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring In-stent restenosis, In-DES-restenosis, paclitaxel, sirolimus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Deutsches Herzzentrum Muenchen
  • 1. Medizinische Klinik, Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Same drug

Different drug

Arm Description

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

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

Outcomes

Primary Outcome Measures

Late luminal loss at follow-up angiography

Secondary Outcome Measures

Need of target lesion revascularization.
Combined incidence of death or myocardial infarction.
Incidence of stent thrombosis.
Incidence of binary restenosis at follow-up angiography

Full Information

First Posted
January 10, 2008
Last Updated
December 16, 2010
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00598715
Brief Title
Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents
Acronym
DESIRE-2
Official Title
Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
In-stent restenosis, In-DES-restenosis, paclitaxel, sirolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Same drug
Arm Type
Experimental
Arm Description
sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
Arm Title
Different drug
Arm Type
Active Comparator
Arm Description
paclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Sirolimus eluting stent
Other Intervention Name(s)
Cypher
Intervention Description
Sirolimus-eluting stent will be implanted
Intervention Type
Device
Intervention Name(s)
Paclitaxel-eluting stent
Other Intervention Name(s)
Taxus
Intervention Description
Paclitaxel-eluting stent will be implanted
Primary Outcome Measure Information:
Title
Late luminal loss at follow-up angiography
Time Frame
6-8 months
Secondary Outcome Measure Information:
Title
Need of target lesion revascularization.
Time Frame
12 months
Title
Combined incidence of death or myocardial infarction.
Time Frame
12 months
Title
Incidence of stent thrombosis.
Time Frame
12 months
Title
Incidence of binary restenosis at follow-up angiography
Time Frame
6-8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julinda Mehilli, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Director
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
1. Medizinische Klinik, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
15644543
Citation
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.
Results Reference
background
PubMed Identifier
20226618
Citation
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.
Results Reference
result
PubMed Identifier
24684757
Citation
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.
Results Reference
derived

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

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