Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Mar 2015
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 31, 2017
April 1, 2017
2.9 years
March 4, 2015
October 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scaffold apposition ratio in both groups (ratio of malapossition stents to total stents per cross-section
Outcome will be analyzed by independent Angio CoreLab based on data recorded during index PCI procedure.
Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary Outcomes (4)
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.
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.
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.
Other Outcomes (4)
Number of patients with diagnosis of periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin)
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Number of patients with diagnosis of in-stent restenosis requiring revascularization within 12 months post-procedure
12 month folow up
Rate of stent thrombosis according the ARC criteria within 12 months post procedure
12 month follow up
- +1 more other outcomes
Study Arms (2)
OPN strategy (study group)
OTHERInterventions 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.
Standard strategy (control group)
OTHERInterventions 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.
Interventions
Target lesion will be prepared by predilatation with OPN NC balloon catheter.
Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
After lesion preparation implantation of BVS Absorb scaffold will be performed.
Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
All patients will be clinically followed for 12 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SIS Medical AGlead
Study Sites (1)
Luzernen Kantonsspital, Spitalstrasse 16
Lucerne, 6000, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florim Cuculi, Prof. dr
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
June 11, 2015
Study Start
March 1, 2015
Primary Completion
February 1, 2018
Study Completion
December 1, 2018
Last Updated
October 31, 2017
Record last verified: 2017-04