CClinicalTrials.gg
Sign In
CompletedNCT00598715DESIRE-2Updated Dec 17, 2010

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

A Phase 4 interventional study of Sirolimus eluting stent and Paclitaxel-eluting stent in Coronary Artery Disease, sponsored by Deutsches Herzzentrum Muenchen. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-17.

Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • In-stent restenosis
  • In-DES-restenosis
  • paclitaxel
  • sirolimus
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 450 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
450 participants (actual)

Study arms

  • Experimental
    Same drug

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

    Device: Sirolimus eluting stent

  • Active comparator
    Different drug

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

    Device: Paclitaxel-eluting stent

Interventions

  • DeviceSirolimus eluting stent

    Sirolimus-eluting stent will be implanted

    Also known as: Cypher

  • DevicePaclitaxel-eluting stent

    Paclitaxel-eluting stent will be implanted

    Also known as: Taxus

06

What researchers measure

Primary outcomes

  1. Late luminal loss at follow-up angiography

    Time frame: 6-8 months

Secondary outcomes

  1. Need of target lesion revascularization.

    Time frame: 12 months

  2. Combined incidence of death or myocardial infarction.

    Time frame: 12 months

  3. Incidence of stent thrombosis.

    Time frame: 12 months

  4. Incidence of binary restenosis at follow-up angiography

    Time frame: 6-8 months

07

Study locations

2 sites
  • Deutsches Herzzentrum Muenchen
    Munich, 80636, Germany
  • 1. Medizinische Klinik, Klinikum rechts der Isar
    Munich, 81675, Germany
08

References and documents

Publications

  • 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. PubMed 15644543 ↗
  • 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. PubMed 20226618 ↗
  • 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. PubMed 24684757 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00598715
Lead sponsor
Deutsches Herzzentrum Muenchen
First posted
Jan 22, 2008
Start date
Oct 2007
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Dec 17, 2010

Study contacts

Adnan Kastrati, MD
principal investigator · Deutsches Herzzentrum Muenchen
Julinda Mehilli, MD
study director · Deutsches Herzzentrum Muenchen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Coronary Artery Disease→

Other studies from this sponsor

Deutsches Herzzentrum Muenchen

Start the discussion