Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06710210

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

Led by University Hospital, Geneva · Updated on 2026-04-29

150

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Geneva

Lead Sponsor

C

Clinical Trials Unit Bern (CTU)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 newer-generation drug-eluting stents (Orsiro Mission, Biotronik AG, Switzerland) for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI with respect to vessel-level absolute change in non-invasive angiography-derived fractional flow reserve (FFRangio, CathWorks, Newport Beach, USA) between post-index PCI and 12-month follow-up. BIOHYBRID is a coronary revascularization strategy study comparing two contemporary treatment approaches for patients with long and/or diffuse coronary artery lesions undergoing PCI. The primary hypothesis of the study is that a hybrid PCI strategy using a 'leave nothing behind' or 'metal-free' approach that combines a bioresorbable magnesium scaffold and drug-coated balloons for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI is feasible. The secondary hypothesis is that a hybrid PCI strategy combining a bioresorbable magnesium scaffold and drug-coated balloons is non-inferior to a conventional DES-based PCI approach using one or several DES for the treatment of patients with long and/or diffuse coronary artery lesions suitable for PCI with respect to vessel-level absolute change in FFRangio (CathWorks, Newport Beach, USA) between post-index PCI and at 12 months of follow-up.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is 18 years or older.
  • Participant has provided written informed consent.
  • Participant is eligible for PCI according to ESC guidelines.
  • Participant is hemodynamically stable.
  • Participant has chronic coronary syndrome or acute coronary syndrome (unstable angina, NSTEMI, or stabilized STEMI).
  • STEMI participants eligible if consent is given 72 hours after successful primary PCI of culprit lesion.
  • Target lesion(s) are not in the STEMI culprit vessel(s).
  • Participant is eligible for dual antiplatelet therapy (aspirin plus clopidogrel, prasugrel, or ticagrelor) for at least 6 months.
  • Participant is willing and able to comply with study protocol and 12-month follow-up angiogram.
  • Target lesion length is greater than 40 mm.
  • Target vessel diameter is between 3.0 and 4.6 mm.
  • Target lesion has baseline TIMI flow grade 1 or higher.
Not Eligible

You will not qualify if you...

  • Known allergy to contrast medium, aspirin, P2Y12 inhibitors, heparin, bivalirudin, components of DES, bioresorbable scaffold, or drug-coated balloon.
  • STEMI within 72 hours before study procedure.
  • Prior PCI in target vessel within last 12 months.
  • On dialysis or serum creatinine over 2.5 mg/dL.
  • Unable to adhere to dual antiplatelet therapy for at least 6 months.
  • On oral anticoagulation unless triple therapy can be maintained for at least 1 month.
  • Life expectancy less than 1 year.
  • Pregnant, breastfeeding, or planning pregnancy during study.
  • Participating or planning participation in another interventional clinical trial (except observational registries).
  • Unable or unwilling to comply with study procedures.
  • Contraindications to medical devices used.
  • Known non-compliance, drug or alcohol abuse.
  • Cognitive or psychological conditions preventing study participation.
  • Participation in another investigational drug or device trial within 30 days prior.
  • Target vessel previously treated with stent within 5 mm of lesion.
  • Target lesion is chronic total occlusion.
  • Target lesion located in left main coronary artery or ostial segments.
  • Target lesion in or supplied by bypass graft.
  • Excessive tortuosity or heavy calcification of target lesion.
  • Need for atherectomy or intravascular lithotripsy before device placement.
  • Target lesion involves bifurcation requiring two devices.
  • Presence of thrombus in target vessel.
  • Planned staged PCI or bypass surgery after study PCI.
  • Unsuccessful lesion preparation or significant angiographic complications.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland, 1205

Actively Recruiting

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Research Team

J

Juan F Iglesias, Principal Investigator

CONTACT

C

Charlotte Kisgen, Study Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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