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

Eligibility & Interventions

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This trial targets 150 participants in total. It began in 2026-04-01 with a primary completion date of 2028-04-01.

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.

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 procedure. 3. Participant is eligible for PCI according to the ESC guidelines (4, 5) . 4. Participant is hemodynamically stable. 5. 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). 5a. 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. 5b. Target lesion(s) to be treated are not located in the STEMI culprit vessel(s) and are not STEMI culprit lesion(s). 6\. Participant is eligible for dual antiplatelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, or ticagrelor for ≥6 months. 7\. 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. Angiographic inclusion criteria 8. Target lesion length is \>40 mm according to operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA), Intravascular Ultrasound (IVUS), or Optical Coherence Tomography (OCT). 9\. 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. 10\. Target lesion with a baseline (pre-PCI) Thrombolysis In Myocardial Infarction (TIMI) flow ≥1. Exclusion criteria: Clinical exclusion criteria 1. 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). 2. Participant with STEMI \<72 hours prior to study index procedure. 12a: Participants with hemodynamically stable NSTEMI are eligible for study enrolment. 3. Participant with prior PCI within the target vessel during the last 12 months prior to the study index procedure. 4. Participant is on dialysis or has chronically impaired renal function defined as serum creatinine \>2.5 mg/dL or 221 μmol/L. 5. Participant is unable to adhere to DAPT for at least 6 months (e.g. planned surgery, dental surgical procedure, active bleeding disorders, active coagulopathy). 6. 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. 7. Participant with life expectancy \<1 year. 8. Participant is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study. 9. Participant unwilling or unable (e.g. physical or cognitive) to comply with study procedures, medication adherence and schedule. 10. Contraindications and limitations of the medical devices as described in the instructions for use. 11. Known or suspected non-compliance, drug or alcohol abuse. 12. Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. 13. Participation in another investigation with an investigational drug or another MD within the 30 days prior to enrolment or during participation in the present investigation is generally not permitted. However, co-enrolment in another interventional clinical investigation may be allowed on a case-by-case basis, provided that: * the investigational interventions are scientifically and clinically distinct, the objectives and primary endpoints of the studies are not competing or confounding, * participation is not expected to interfere with participant safety, investigational device performance, or interpretation of the BIOHYBRID study endpoints. Angiographic exclusion criteria 14. 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. 15. Target lesion is a chronic total occlusion. 16. Target lesion is located in left main coronary artery, ostial left anterior descending artery, ostial left circumflex artery, or ostial right coronary artery (within 5.0 mm of the vessel origin). 17. Target lesion is located in, or supplied by, an arterial or venous bypass graft. 18. Target lesion with excessive tortuosity proximal to or within the lesion based on operator visual estimation, or heavily calcified target lesion which may be adequately prepared using a non-compliant and/or cutting/scoring balloon. 19. Target lesion requires treatment with a device other than a non-compliant balloon and/or a modified (cutting/scoring) balloon prior to scaffold/stent placement (including but not limited to atherectomy devices, intravascular lithotripsy). 20. Target lesion involves a coronary bifurcation with a side branch with reference vessel diameter ≥2.0 mm that requires a two-device strategy after pre-dilatation. 21. Presence of thrombus in the target vessel. 22. Future planned staged PCI or coronary artery bypass graft surgery after the study PCI procedure. 23. Target with unsuccessful lesion preparation, defined as the absence of residual stenosis ≥30%, TIMI flow grade \<3 following complete lesion preparation (6), type C to F coronary artery dissection according to the National Heart, Lung and Blood Institute (NHLBI) classification (7) (Appendix 2) and angiographic complications (e.g. distal embolization, or side branch closure).

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