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Coronary Artery Disease
+2

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

Sponsored by University Hospital, Geneva

About this trial

Last updated 8 months ago

Study ID

2024-0000

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 6 months ago

What is this trial 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.

What are the participation requirements?

Yes

Inclusion Criteria

- Clinical inclusion criteria

1. Subject is ≥18 years.
2. Subject 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. Subject is eligible for PCI according to the ESC guidelines.
4. Subject with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS): unstable angina, hemodynamically stable non-ST-segment elevation myocardial infarction (NSTEMI), or stabilized ST-segment elevation myocardial infarction (STEMI). Note: subjects with STEMI are eligible for the treatment of non-culprit coronary lesions, if:
- Subject consent occurs ≥72 hours after successful primary PCI of the culprit STEMI lesion, and
- Subject is hemodynamically stable, and
- Target lesion(s) to be treated are not located in the STEMI culprit vessel(s) and are not STEMI culprit lesion(s).
5. Subject is eligible for dual antiplatelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, or ticagrelor for ≥6 months.
6. Subject 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

1. 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).
2. 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.
3. Target lesion with a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1.
No

Exclusion Criteria

- Clinical exclusion criteria

1. Subject 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. Subject with STEMI <72 hours prior to study index procedure. Note: Subjects with hemodynamically stable NSTEMI are eligible for study enrollment.
3. Subject with prior PCI within the target vessel during the last 12 months prior to the study index procedure.
4. Subject is on dialysis or with chronically impaired renal function (serum creatinine >2.5 mg/dl or 221 micromol/l)
5. Subject is unable to adhere to DAPT for at least 6 months (e.g. planned surgery, dental surgical procedure, active bleeding disorders, active coagulopathy).
6. Subject 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. Subject with life expectancy <1 year.
8. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
9. Subject is currently participating or planning to participate in another interventional clinical trial, except for observational registries.
10. Subject unwilling or unable (e.g. physical or cognitive) to comply with study procedures, medication adherence and schedule.

- Angiographic exclusion criteria

1. 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.
2. Target lesion is a chronic total occlusion.
3. 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).
4. Target lesion is located in, or supplied by, an arterial or venous bypass graft.
5. 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.
6. 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).
7. 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.
8. Presence of thrombus in the target vessel.
9. Future planned staged PCI or coronary artery bypass graft surgery in the target vessel.
10. Target lesion with unsuccessful lesion preparation, defined as the absence of residual stenosis ≥30%, Thrombolysis in Myocardial Infarction (TIMI) flow grade <3, type C to F coronary artery dissection according to the National Heart, Lung and Blood Institute (NHLBI) classification (Appendix) and angiographic complications (e.g. distal embolization, or side branch closure).

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Status