Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)
- Conditions
- Stable AnginaAnginaUnstable AnginaCoronary Artery Disease
- Registration Number
- NCT02468960
- Lead Sponsor
- SIS Medical AG
- 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
* 25 in the OPN strategy (study group)
* 25 in the standard strategy (control group)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 44
- 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 <0.80.
- 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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section 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 Outcome Measures
Name Time Method 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. Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
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.
Trial Locations
- Locations (1)
Luzernen Kantonsspital, Spitalstrasse 16
🇨🇭Luzern, Switzerland
Luzernen Kantonsspital, Spitalstrasse 16🇨🇭Luzern, Switzerland