Bioresorbable Scaffold Combined with Drug-Coated Balloons for Hybrid Percutaneous Coronary Intervention Compared to a Conventional Strategy Based on Drug-Eluting Stents in Patients with Long and Diffuse Coronary Artery Disease: Randomized BIOHYBRID Pilot Study

Switzerland (ICTRP)

ID di studio ICTRP
NCT06710210 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
BIOresorbable scaffold combined with drug-coated balloons for HYBRID percutaneous coronary intervention versus a conventional drug-eluting stent-based strategy in patients with long and diffuse coronary artery disease: BIOHYBRID randomized pilot trial (BASEC)

Titolo accademico
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: the BIOHYBRID Randomized Pilot Trial (ICTRP)

Titolo pubblico
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 (ICTRP)

Malattie studiate
Coronary Artery DiseaseDiffuse Coronary Artery DiseasePercutaneous Coronary Intervention (PCI) (ICTRP)

Intervento studiato
Device: PCI with a bioresorbable scaffold and drug-coated balloon(s)Device: PCI with drug-eluting stent(s) (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
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 mol/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 is currently participating or planning to participate in another
interventional clinical trial, except for observational registries or previous
enrolment into the current investigation.

10. Participant unwilling or unable (e.g. physical or cognitive) to comply with study
procedures, medication adherence and schedule.

11. Contraindications and limitations of the medical devices as described in the
instructions for use.

12. Known or suspected non-compliance, drug or alcohol abuse.

13. Inability to follow the procedures of the investigation, e.g. due to language
problems, psychological disorders, dementia, etc. of the participant.

14. Participation in another investigation with an investigational drug or another MD
within the 30 days preceding and during the present investigation.

Angiographic exclusion criteria

15. 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.

16. Target lesion is a chronic total occlusion.

17. 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).

18. Target lesion is located in, or supplied by, an arterial or venous bypass graft.

19. 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.

20. 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).

21. 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.

22. Presence of thrombus in the target vessel.

23. Future planned staged PCI or coronary artery bypass graft surgery after the study
PCI procedure.

24. 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). (ICTRP)

non disponibile

Endpoint primari e secondari
Vessel-level delta FFRangio values between post-PCI and 12-month follow-up (ICTRP)

Vessel-level FFRangio value after index PCI;Vessel-level FFRangio value at 12-month follow-up;Rate of target vessel failure (ICTRP)

Data di registrazione
25.11.2024 (ICTRP)

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Clinical Trials Unit Bern (CTU) (ICTRP)

Contatti aggiuntivi
Juan F Iglesias, Principal Investigator;Juan F Iglesias, Principal Investigator, juanfernando.iglesias@hug.ch, +41795533467;+41795533467 (ICTRP)

ID secondari
2024-0000 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06710210 (ICTRP)