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Compares treatment options for Coronary Artery Disease
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
ClinicalTrials.gov ID: NCT06710210
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Clinical 1. 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...
- 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...
You likely can't join if
- Clinical exclusion criteria
- Participant has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy or intolerance to aspirin, P2Y12...
- Participant with STEMI \<72 hours prior to study index procedure. 12a: Participants with hemodynamically stable NSTEMI are eligible for study...
- 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...
See the full eligibility criteria
Who can join
- Clinical 1. 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...
What rules you out
- Clinical exclusion criteria
- 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...
- 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 treatment 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. Angiographic exclusion criteria
- 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.
- Target lesion is a chronic total occlusion.
- 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).
- Target lesion is located in, or supplied by, an arterial or venous bypass graft.
- 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...
- 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...
- 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.
- Presence of thrombus in the target vessel.
- Future planned staged PCI or coronary artery bypass graft surgery after the study PCI procedure.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Canton of Geneva, Switzerland
- Basel, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Canton of Geneva, Switzerland; Basel, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.