Bioresorbable Scaffold and Drug-coated Balloons for Heart Disease

Hybrid Percutaneous Coronary Intervention Combining a Bioresorbable Scaffold With Drug-coated Balloons Versus a Conventional Drug-eluting Stent-based Strategy in Patients With Long and Diffuse Coronary Artery Disease

Recruiting N/A Interventional Study
Coronary Artery Disease Diffuse Coronary Artery Disease Percutaneous Coronary Intervention (PCI)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
150 (estimated)
Sponsor
University Hospital, Geneva · Other
Who this trial is looking for

This trial is looking for adults with long or diffuse coronary artery disease. Participants will undergo a specific heart procedure using a unique combination of treatments and will be followed for 12 months to see the results.

Are You a Good Fit for This Trial?
Rules you out Life expectancy less than 1 yearChronic total occlusion of the target lesionSevere kidney impairmentActive bleeding disorders

You may be able to join if

  • I am at least 18 years old.
  • I can provide written consent for the study.
  • I am eligible for a heart procedure according to guidelines.
  • I am hemodynamically stable.
  • I have chronic coronary syndrome or have had an unstable type of heart condition.
  • I can take specific medications for at least 6 months.
  • I am willing to participate in the study and complete the required visits.
  • My target heart artery lesion is longer than 40 mm.

You may not be able to join if

  • I am allergic to contrast medium or certain heart medications.
  • I had a heart attack within the last 72 hours.
  • I had a heart procedure in the target vessel in the last 12 months.
  • I am on dialysis or have severely impaired kidney function.
  • I cannot adhere to the required medication for 6 months.
  • I am on blood-thinning medication that cannot be safely stopped.
  • I am pregnant or breastfeeding.
  • I am currently involved in another clinical trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
The primary objective of the study is to assess the safety and the efficacy of a hybrid percutaneous coronary intervention (PCI) strategy combining a magnesium-based sirolimus-eluting bioresorbable scaffold (Freesolve, Biotronik AG, Switzerland) and ≥1 paclitaxel-eluting drug-coated balloon(s) (Pantera Lux, Biotronik AG, Switzerland) compared to a conventional DES-based PCI approach using \>1 newe…
Trial Locations
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Eligibility Criteria
Inclusion criteria: * Clinical inclusion criteria 1. Participant is ≥18 years. 2. Participant has provided written informed consent as approved by the independent Ethical Committee (EC) or Institutional Review Board (IRB) of the respective participating centre prior to any study-related proced…
Contacts

Juan F Iglesias, Principal Investigator

+41795533467

juanfernando.iglesias@hug.ch

CONTACT

Charlotte Kisgen, Study Coordinator

+41795530593

charlotte.kisgen@hug.ch

CONTACT