Coronary Artery DiseaseISAR-DESIRE5NCT05544864
Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5
A study testing Drug eluting stent (DES) and Drug coated ballloon (DCB) in people with Coronary Artery Disease and Restenoses, Coronary, run by Deutsches Herzzentrum Muenchen at 5 sites in 2 countries.
Trial summary
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Restenoses, Coronary
- What is being tested?
- Drug eluting stent (DES) and Drug coated ballloon (DCB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 28 Sep 2022to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 with ischemic symptoms and/or evidence of myocardial ischemia
- Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
- Availability of an OCT-pullback of the target lesion
- Written informed consent by the patient for participation in the study.
- Age ≥ 18 years
Who cannot join
- Cardiogenic shock
- Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
- Target lesion located in left main trunk or bypass graft.
- Additional coronary intervention planned within 30 days of the procedure.
- Non-successful treatment of other lesion(s) during the same procedure
- Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
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- Contraindications to any components of the investigational devices or dual antiplatelet therapy
- Pregnancy (present, suspected or planned) or positive pregnancy test.
- Previous enrollment in this trial or participation in any other study at the time of enrollment.
- Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.
- Patient's inability to fully comply with the study protocol
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Germany4 sites, 4 recruiting
- Recruiting
Elisabeth-Krankenhaus Essen GmbH
Essen, 45138
Thomas Schmitz, Dr. med., +49 201 8973200, t.schmitz@contilia.de
Tobias Weinreich, Dr. med., +49 201 8973200, t.weinreich@contilia.de
- Recruiting
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, D-60596
David M Leistner, Prof. MD, david.leistner@herz-frankfurt.de
Lena Marie Seegers, MD, lena.seegers@herz-frankfurt.de
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, D-20246
Fabian J Brunner, MD, fa.brunner@uke.de
Peter M Becher, MD, m.becher@uke.de
- Recruiting
Deutsches Herzzentrum München
Munich, 80636
Felix Voll, MD, +49 89 1218 ext. 2749, voll@dhm.mhn.de
Salvatore Cassese, MD, PHD, +49 89 1218 ext. 2764, cassese@dhm.mhn.de
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de La Princesa Madrid
Madrid, Madrid, 28006
Fernando Alfonso, Prof. Dr., +34-680483165, falf@hotmail.com
Fernando Alfonso, Prof. Dr.
About this study
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.
- Conditions
- Coronary Artery Disease, Restenoses, Coronary
- Being tested
- Drug eluting stent (DES), Drug coated ballloon (DCB)
- Medical subject headings
- Coronary Artery Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting stent (DES)Device
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
Drug coated ballloon (DCB)Device
DCB angioplasty with any commercially available drug-coated balloon
| Study group | Role | What they receive |
|---|---|---|
| homogenous | Other | Stratification - homogenous pattern Receives: Device: Drug eluting stent (DES); Device: Drug coated ballloon (DCB) |
| heterogenous | Other | Stratification - homogenous pattern Receives: Device: Drug eluting stent (DES); Device: Drug coated ballloon (DCB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of major adverse cardiac event (MACE)
Composite endpoint of major adverse cardiac event (MACE)
- all-cause death
- myocardial infarction
- target lesion revascularization (TLR)
Measured: 24 months of clinical follow-up after randomization
Secondary outcomes (4)
Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR
Measured: 24 months of clinical follow-up after randomization
Individual endpoints of the composite endpoints
- all-cause death
- myocardial infarction
- target lesion revascularization (TLR)
Measured: 24 months of clinical follow-up after randomization
Stent thrombosis according to the ARC criteria
Measured: 24 months of clinical follow-up after randomization
Safety endpoint: a composite endpoint of all-cause death and myocardial infarction
Measured: 24 months of clinical follow-up after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start28 Sep 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- EvidentIQ Germany GmbH, Abbott, Technical University of Munich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544864
- Sponsor's protocol ID
- GE IDE no. BA00219
- Acronym
- ISAR-DESIRE5
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2022
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simonetti F, Voll F, Alfonso F, Grasser C, Janisch M, Joner M, Kessler T, Kuna C, Leistner DM, Lenz T, Presch A, Rheude T, Sager H, Schunkert H, Starnecker F, Wiebe J, Kastrati A, Cassese S, Xhepa E. Intracoronary Stenting and Restenosis - Randomized Trial of Drug-Eluting Stent Implantation or Drug-Coated Balloon Angioplasty According to Neointima Morphology in Drug-Eluting Stent REstenosis 5: Rationale and Design of the ISAR-DESIRE 5 Trial. J Cardiovasc Transl Res. 2025 Oct;18(5):1176-1184. doi: 10.1007/s12265-025-10650-x. Epub 2025 Jun 30.
PubMed 40588613
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5
- ClinicalTrials.gov ID
- NCT05544864
- Acronym / sponsor ID
- ISAR-DESIRE5 / GE IDE no. BA00219
- Conditions
- Coronary Artery Disease, Restenoses, Coronary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- EvidentIQ Germany GmbH, Abbott, Technical University of Munich
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Sep 2022 (actual)
- 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.
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| homogenous | Other | Device: Drug eluting stent (DES), Device: Drug coated ballloon (DCB)Stratification - homogenous pattern |
| heterogenous | Other | Device: Drug eluting stent (DES), Device: Drug coated ballloon (DCB)Stratification - homogenous pattern |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with ischemic symptoms and/or evidence of myocardial ischemia
- Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
- Availability of an OCT-pullback of the target lesion
- Written informed consent by the patient for participation in the study.
- Age ≥ 18 years
Key exclusion criteria (11 listed)
- Cardiogenic shock
- Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
- Target lesion located in left main trunk or bypass graft.
- Additional coronary intervention planned within 30 days of the procedure.
- Non-successful treatment of other lesion(s) during the same procedure
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 |
|---|---|---|
| Drug eluting stent (DES)DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular) | Device | heterogenous, homogenous |
| Drug coated ballloon (DCB)DCB angioplasty with any commercially available drug-coated balloon | Device | heterogenous, homogenous |
Primary outcome
Composite endpoint of major adverse cardiac event (MACE)
Time frame: 24 months of clinical follow-up after randomization
Composite endpoint of major adverse cardiac event (MACE) * all-cause death * myocardial infarction * target lesion revascularization (TLR)
4 secondary outcomes
Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR
Time frame: 24 months of clinical follow-up after randomization
Individual endpoints of the composite endpoints
Time frame: 24 months of clinical follow-up after randomization
Stent thrombosis according to the ARC criteria
Time frame: 24 months of clinical follow-up after randomization
Safety endpoint: a composite endpoint of all-cause death and myocardial infarction
Time frame: 24 months of clinical follow-up after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Derived from this study: PubMed 40588613Simonetti F, Voll F, Alfonso F, Grasser C, Janisch M, Joner M, Kessler T, Kuna C, Leistner DM, Lenz T, Presch A, Rheude T, Sager H, Schunkert H, Starnecker F, Wiebe J, Kastrati A, Cassese S, Xhepa E. Intracoronary Stenting and Restenosis - Randomized Trial of Drug-Eluting Stent Implantation or Drug-Coated Balloon Angioplasty According to Neointima Morphology in Drug-Eluting Stent REstenosis 5: Rationale and Design of the ISAR-DESIRE 5 Trial. J Cardiovasc Transl Res. 2025 Oct;18(5):1176-1184. doi: 10.1007/s12265-025-10650-x. Epub 2025 Jun 30.
- Individual participant dataSharing planned: No
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug eluting stent (DES) and Drug coated ballloon (DCB) in people with Coronary Artery Disease and Restenoses, Coronary, run by Deutsches Herzzentrum Muenchen at 5 sites in 2 countries.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Spain. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Voll, MD (+49 89 1218 2749, voll@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of major adverse cardiac event (MACE) (time frame: 24 months of clinical follow-up after randomization). 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 NCT05544864, which also lists 1 linked publication.
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 6 Jan 2025.