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 (ISAR-DESIRE5)

January 3, 2025 updated by: Deutsches Herzzentrum Muenchen
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
376

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Felix Voll, MD
  • Phone Number: +49 89 1218 2749
  • Email: voll@dhm.mhn.de

Study Contact Backup

  • Name: Salvatore Cassese, MD, PHD
  • Phone Number: +49 89 1218 2764
  • Email: cassese@dhm.mhn.de

Study Locations

  • Germany
      • Essen, Germany, 45138
        • Recruiting
        • Elisabeth-Krankenhaus Essen GmbH
        • Contact:
        • Contact:
      • Hamburg, Germany, D-20246
      • Munich, Germany, 80636
        • Recruiting
        • Deutsches Herzzentrum München
        • Contact:
        • Contact:
        • Principal Investigator:
          • Felix Voll, MD
    • Hessen
  • Spain
    • Community Of Madrid
      • Madrid, Community Of Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa Madrid
        • Contact:
          • Fernando Alfonso, Prof. Dr.
          • Phone Number: +34-680483165
          • Email: falf@hotmail.com
        • Principal Investigator:
          • Fernando Alfonso, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with ischemic symptoms and/or evidence of myocardial ischemia
  2. Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
  3. Availability of an OCT-pullback of the target lesion
  4. Written informed consent by the patient for participation in the study.
  5. Age ≥ 18 years

Exclusion Criteria:

  1. Cardiogenic shock
  2. Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
  3. Target lesion located in left main trunk or bypass graft.
  4. Additional coronary intervention planned within 30 days of the procedure.
  5. Non-successful treatment of other lesion(s) during the same procedure
  6. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
  7. Contraindications to any components of the investigational devices or dual antiplatelet therapy
  8. Pregnancy (present, suspected or planned) or positive pregnancy test.
  9. Previous enrollment in this trial or participation in any other study at the time of enrollment.
  10. Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.
  11. Patient's inability to fully comply with the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: homogenous
Stratification - homogenous pattern
Device: Drug eluting stent (DES)
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
Device: Drug coated ballloon (DCB)
DCB angioplasty with any commercially available drug-coated balloon
Other: heterogenous
Stratification - homogenous pattern
Device: Drug eluting stent (DES)
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
Device: Drug coated ballloon (DCB)
DCB angioplasty with any commercially available drug-coated balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
24 months of clinical follow-up after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
24 months of clinical follow-up after randomization
Individual endpoints of the composite endpoints
Time Frame: 24 months of clinical follow-up after randomization
  • all-cause death
  • myocardial infarction
  • target lesion revascularization (TLR)
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
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
24 months of clinical follow-up after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Deutsches Herzzentrum Muenchen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott
Technical University of Munich
EvidentIQ Germany GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GE IDE no. BA00219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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