Coronary Artery DiseasePhase 4DESIRE-2NCT00598715
Efficacy Study of Two Different Strategies for Restenosis in Sirolimus-Eluting Stents
A Phase 4 study testing Sirolimus eluting stent and Paclitaxel-eluting stent in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sirolimus eluting stent and Paclitaxel-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2007to Aug 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Deutsches Herzzentrum Muenchen
Munich, 80636
1. Medizinische Klinik, Klinikum rechts der Isar
Munich, 81675
About this study
Official title: Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents
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
- Conditions
- Coronary Artery Disease
- Being tested
- Sirolimus eluting stent, Paclitaxel-eluting stent
- Keywords
- In-stent restenosis, In-DES-restenosis, paclitaxel, sirolimus
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus eluting stentDevice
Also called Cypher
Sirolimus-eluting stent will be implanted
Paclitaxel-eluting stentDevice
Also called Taxus
Paclitaxel-eluting stent will be implanted
| Study group | Role | What they receive |
|---|---|---|
| Same drug | Experimental | sirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent Receives: 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 Receives: Device: Paclitaxel-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late luminal loss at follow-up angiography
Measured: 6-8 months
Secondary outcomes (4)
Need of target lesion revascularization.
Measured: 12 months
Combined incidence of death or myocardial infarction.
Measured: 12 months
Incidence of stent thrombosis.
Measured: 12 months
Incidence of binary restenosis at follow-up angiography
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Adnan Kastrati, MD, Principal investigator, Deutsches Herzzentrum MuenchenJulinda Mehilli, MD, Study director, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598715
- Sponsor's protocol ID
- GE IDE No. S02407
- Acronym
- DESIRE-2
- Status last verified
- Sep 2009
- First submitted
- 10 Jan 2008
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
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 15644543Mehilli 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 20226618Kufner 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Paclitaxel- vs Sirolimus-eluting Stents for Treatment of Coronary Restenosis in Sirolimus-eluting Stents
- ClinicalTrials.gov ID
- NCT00598715
- Acronym / sponsor ID
- DESIRE-2 / GE IDE No. S02407
- Conditions
- Coronary Artery Disease
- Keywords
- In-stent restenosis, In-DES-restenosis, paclitaxel, sirolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same drug | Experimental | Device: Sirolimus eluting stentsirolimus-eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent |
| Different drug | Active comparator | Device: Paclitaxel-eluting stentpaclitaxel eluting stent will be implanted for restenosis after previous the implantation of a sirolimus-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sirolimus eluting stentAlso: CypherSirolimus-eluting stent will be implanted | Device | Same drug |
| Paclitaxel-eluting stentAlso: TaxusPaclitaxel-eluting stent will be implanted | Device | Different drug |
Primary outcome
Late luminal loss at follow-up angiography
Time frame: 6-8 months
4 secondary outcomes
Need of target lesion revascularization.
Time frame: 12 months
Combined incidence of death or myocardial infarction.
Time frame: 12 months
Incidence of stent thrombosis.
Time frame: 12 months
Incidence of binary restenosis at follow-up angiography
Time frame: 6-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
- Background: PubMed 15644543Kastrati 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 publication: PubMed 20226618Mehilli 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.
- Derived from this study: PubMed 24684757Kufner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Kastrati, MD principal investigator
Deutsches Herzzentrum Muenchen
Julinda Mehilli, MD study director
Deutsches Herzzentrum Muenchen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sirolimus eluting stent and Paclitaxel-eluting stent in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late luminal loss at follow-up angiography (time frame: 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00598715, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2010.