Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
Study Overview
Brief Summary
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold).
Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.
Detailed Description
Study design:
Following pre-dilatation a BVS will be implanted and optical coherence tomography (OCT) will be performed in all patients. After OCT post-dilatation with non-compliant balloons might be performed if this is considered necessary by the treating interventionist. Final OCT will be performed in all patients. 1:1 Randomization of two strategies before the implantation of bioresorbable scaffolds:
- OPN strategy (study group): pre-dilatation with OPN NC ® Super High Pressure PTCA (Percutaneous Transluminal Coronary Angioplasty) balloons
- standard strategy (control group): pre-dilatation with a standard (compliant) balloon
Enrolment:
Randomization of 50 patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years.
- •Able and willing to give informed consent.
- •Willing to comply with specified follow-up evaluations.
- •Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction.
- •De novo lesion.
- •Angiographic diameter stenosis > 70 % and/or fractional flow reserve <0.
- •Vessel diameter between 2.5 and 4.0 mm.
- •One- or two vessel disease (defined as diameter stenosis > 70 % in vessels with a diameter > 2.5 mm).
- •Up to two lesions in one or two vessels can be treated
Exclusion Criteria
- •Patient characteristics
- •Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure.
- •Patient with contraindication for 12 months of dual antiplatelet therapy.
- •ST-elevation myocardial infarction.
- •Any contraindication to the implantation of BVS. Lesion characteristics
- •Visible thrombus in coronary angiography
- •Chronic total occlusion
Arms & Interventions
OPN strategy (study group)
Interventions planned in this arm are as follows:
- Predilatation with OPN NC balloon catheter.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
Intervention: Predilatation with OPN NC balloon catheter. (Device)
OPN strategy (study group)
Interventions planned in this arm are as follows:
- Predilatation with OPN NC balloon catheter.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
Intervention: Absorb BVS implantation. (Device)
OPN strategy (study group)
Interventions planned in this arm are as follows:
- Predilatation with OPN NC balloon catheter.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
Intervention: Treated segment visualization by OCT. (Procedure)
OPN strategy (study group)
Interventions planned in this arm are as follows:
- Predilatation with OPN NC balloon catheter.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
Intervention: Clinical FU at 12 months. (Other)
Standard strategy (control group)
Interventions planned in this arm are as follows:
- Predilatation with standard compliant balloon.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
Intervention: Predilatation with standard compliant balloon. (Device)
Standard strategy (control group)
Interventions planned in this arm are as follows:
- Predilatation with standard compliant balloon.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
Intervention: Absorb BVS implantation. (Device)
Standard strategy (control group)
Interventions planned in this arm are as follows:
- Predilatation with standard compliant balloon.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
Intervention: Treated segment visualization by OCT. (Procedure)
Standard strategy (control group)
Interventions planned in this arm are as follows:
- Predilatation with standard compliant balloon.
- Absorb BVS implantation.
- Treated segment visualization by OCT.
- Clinical FU at 12 months.
Intervention: Clinical FU at 12 months. (Other)
Outcomes
Primary Outcomes
Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
Time Frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
Secondary Outcomes
- Need for post-dilatation after implantation of the scaffold(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)
- Procedural success defined as successful delivery of the scaffold(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)
- Scaffold apposition after post-dilatation(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)
- Frequency and total number of periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation,(Participants will be followed for the duration of index procedure, an expected average of 1 hour.)