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

NCT06710210 | Recruiting

• 1 other identifier: 2024-0000
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Coronary Artery Disease; Diffuse Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)

Keywords

Diffuse/long coronary artery disease; Percutaneous coronary intervention; Drug-eluting stents; Drug-coated balloons; Bioresorbable scaffold

Outcome Measures

Primary Outcomes (1)

• Vessel-level delta FFRangio values between post-PCI and 12-month follow-up

  Vessel-level delta angiography-derived Fractional Flow Reserve values between post-PCI and 12-month follow-up

  12 months

Secondary Outcomes (3)

• Vessel-level FFRangio value after index PCI

  After index PCI

• Vessel-level FFRangio value at 12-month follow-up

  12 months

• Rate of target vessel failure

  12 months

Other Outcomes (7)

• Rate of vessel-oriented composite endpoint (VOCE)

  12 months.

• Rate of all-cause death

  12 months

• Rate of any myocardial infarction

  12 months

Study Arms (2)

Hybrid PCI strategy

EXPERIMENTAL

Hybrid percutaneous coronary intervention with a bioresorbable scaffold and drug-coated balloon(s)

Device: PCI with a bioresorbable scaffold and drug-coated balloon(s)

Conventional PCI strategy

ACTIVE COMPARATOR

Percutaneous coronary intervention with drug-eluting stent(s)

Device: PCI with drug-eluting stent(s)

Interventions

PCI with drug-eluting stent(s) DEVICE

PCI with \>1 newer-generation drug-eluting stent (Orsiro Mission, Biotronik AG, Switzerland)

Conventional PCI strategy

PCI with a bioresorbable scaffold and drug-coated balloon(s) DEVICE

Hybrid PCI 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)

Hybrid PCI strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is ≥18 years.
• 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 procedure.
• Participant is eligible for PCI according to the ESC guidelines (4, 5) .
• Participant is hemodynamically stable.
• Participant with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS): unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or stabilized ST-segment elevation myocardial infarction (STEMI).
• a. Participants with STEMI are eligible for the treatment of non-culprit coronary lesions, if participant consent occurs ≥72 hours after successful primary PCI of the culprit STEMI lesion.
• b. Target lesion(s) to be treated are not located in the STEMI culprit vessel(s) and are not STEMI culprit lesion(s).
• \. Participant is eligible for dual antiplatelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, or ticagrelor for ≥6 months.
• \. Participant is willing to participate and able to comply with the protocol requirements for the duration of the study, including completion of study visits and control coronary angiogram at 12 months.
• \. Target vessel has a maximum reference diameter between 3.0-4.6 mm according to operator visual estimation, which may be assisted by QCA, IVUS, or OCT.
• Notes: The proximal segment, which has a larger vessel diameter, will be treated with one Freesolve scaffold, in accordance with the vessel diameter range specified in the IFU. The distal segment, which naturally tapers to a smaller diameter, can be treated with one or more Pantera Lux DCB, in accordance with the vessel diameter range specified in the IFU.
• \. Target lesion with a baseline (pre-PCI) Thrombolysis In Myocardial Infarction (TIMI) flow ≥1.

You may not qualify if:

• Participant has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy or intolerance to aspirin, P2Y12 receptor inhibitors (clopidogrel, ticagrelor, or prasugrel), both heparin and bivalirudin, any of the following DES or bioresorbable scaffold component (magnesium, aluminium, tantalum, poly-L-lactide, or sirolimus), or drug-coated balloon component (paclitaxel).
• Participant with STEMI \<72 hours prior to study index procedure. 12a: Participants with hemodynamically stable NSTEMI are eligible for study enrolment.
• Participant with prior PCI within the target vessel during the last 12 months prior to the study index procedure.
• Participant is on dialysis or has chronically impaired renal function defined as serum creatinine \>2.5 mg/dL or 221 μmol/L.
• Participant is unable to adhere to DAPT for at least 6 months (e.g. planned surgery, dental surgical procedure, active bleeding disorders, active coagulopathy).
• Participant is on oral anticoagulation therapy (OAC) prior to index procedure unless DAPT plus OAC (i.e. triple therapy) can be maintained for a minimum of 1 month.
• Participant with life expectancy \<1 year.
• Participant is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
• Participant is currently participating or planning to participate in another interventional clinical trial, except for observational registries or previous enrolment into the current investigation.
• Participant unwilling or unable (e.g. physical or cognitive) to comply with study procedures, medication adherence and schedule.
• Contraindications and limitations of the medical devices as described in the instructions for use.
• Known or suspected non-compliance, drug or alcohol abuse.
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation.
• Target vessel previously treated with a bare-metal stent or a drug-eluting stent and the target lesion is within 5 mm proximal or distal to the previously treated lesion.

Sponsors & Collaborators

• Clinical Trials Unit Bern (CTU): collaborator
• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Juan F Iglesias, Principal Investigator

CONTACT

+41795533467; juanfernando.iglesias@hug.ch

Charlotte Kisgen, Study Coordinator

CONTACT

+41795530593; charlotte.kisgen@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)