Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)
NCT ID: NCT02468960
Last Updated: 2017-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
44 participants
INTERVENTIONAL
2015-03-31
2018-12-31
Brief Summary
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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
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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)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Predilatation with OPN NC balloon catheter.
Target lesion will be prepared by predilatation with OPN NC balloon catheter.
Absorb BVS implantation.
After lesion preparation implantation of BVS Absorb scaffold will be performed.
Treated segment visualization by OCT.
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
Clinical FU at 12 months.
All patients will be clinically followed for 12 months.
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.
Predilatation with standard compliant balloon.
Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
Absorb BVS implantation.
After lesion preparation implantation of BVS Absorb scaffold will be performed.
Treated segment visualization by OCT.
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
Clinical FU at 12 months.
All patients will be clinically followed for 12 months.
Interventions
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Predilatation with OPN NC balloon catheter.
Target lesion will be prepared by predilatation with OPN NC balloon catheter.
Predilatation with standard compliant balloon.
Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
Absorb BVS implantation.
After lesion preparation implantation of BVS Absorb scaffold will be performed.
Treated segment visualization by OCT.
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
Clinical FU at 12 months.
All patients will be clinically followed for 12 months.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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SIS Medical AG
INDUSTRY
Responsible Party
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Principal Investigators
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Florim Cuculi, Prof. dr
Role: PRINCIPAL_INVESTIGATOR
Locations
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Luzernen Kantonsspital, Spitalstrasse 16
Lucerne, , Switzerland
Countries
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Other Identifiers
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OPreNBiS
Identifier Type: -
Identifier Source: org_study_id