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Comparing two treatments for coronary arteries that narrowed again after stenting

Compares a drug-eluting stent with a drug-coated balloon in adults with repeated artery narrowing.

Key facts

Who runs it
Deutsches Herzzentrum Muenchen
Where
Essen, Frankfurt am Main, Hamburg, and Munich, GermanySee the 4 sitesAlso in 1 other country, 1 site
Trial code
Registry 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
Status
Recruiting
People taking part
376 people, planned
Started
28 Sept 2022
Planned end
Sept 2026
Type of study
Interventional, 2 groups
Treatments tested
  • Drug eluting stent (DES)
  • Drug coated ballloon (DCB)
Record updated
6 January 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose earlier drug-eluting heart stent has narrowed again and who have symptoms or signs of poor blood flow to the heart.

Age
18 years or older
Sex
Men and women
Disease stage
At least 50% narrowing of a heart artery after an earlier drug-eluting stent was placed, with symptoms or signs of poor blood flow to the heart. An OCT scan of the narrowed spot must be available.
Earlier treatment
A drug-eluting stent must have been placed earlier in a native coronary artery.

Main reasons for not taking part

  • Cardiogenic shock
  • ST-elevation heart attack within the last 48 hours
  • Narrowing in the left main trunk or in a bypass graft
  • Severe kidney problems (glomerular filtration rate of 30 ml/min or less)
  • Pregnancy (present, suspected or planned)

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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 take part

  • Contraindications to any components of the investigational devices or dual antiplatelet therapy
  • Previous enrollment in this trial or participation in any other study at the time of enrollment
  • Acute ST-elevation myocardial infarction within 48 hours from symptom onset
  • Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
  • Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance
  • Cardiogenic shock
  • 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
  • Pregnancy (present, suspected or planned) or positive pregnancy test
  • Patient's inability to fully comply with the study protocol

Where in Germany

Also in 1 other country, 1 site

  • Elisabeth-Krankenhaus Essen GmbHEssen, GermanyContact: Thomas Schmitz, Dr. med.Taking people
  • Universitätsklinikum FrankfurtFrankfurt am Main, GermanyContact: David M Leistner, Prof. MDTaking people
  • Universitätsklinikum Hamburg-EppendorfHamburg, GermanyContact: Fabian J Brunner, MDTaking people
  • Deutsches Herzzentrum MünchenMunich, GermanyContact: Felix Voll, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • homogenousOther group

    Stratification - homogenous pattern

    Treatment: Drug eluting stent (DES) and Drug coated ballloon (DCB)

  • heterogenousOther group

    Stratification - homogenous pattern

    Treatment: Drug eluting stent (DES) and Drug coated ballloon (DCB)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Comparing two treatments for coronary arteries that narrowed again after stentingGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 January 2025