Coronary Artery Disease Clinical Trial
— OPreNBiSOfficial title:
Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
NCT number | NCT03518645 |
Other study ID # | OPreNBiS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | March 29, 2018 |
Verified date | May 2018 |
Source | KCRI |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons
before implantation of BVS.
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | March 29, 2018 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 <0.80. - 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: 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Luzerner Kantonsspital | Luzern |
Lead Sponsor | Collaborator |
---|---|
KCRI | SIS Medical AG |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apposition of bioresorbable scaffold immediately after stent implantation following: pre-dilatation with OPN vs. pre-dilatation with standard balloons. | Stent apposition will be assessed based on OCT (optical coherence tomography) visualization. | During the index procedure | |
Secondary | Procedural success defined as successful delivery of the scaffold. | The frequency of procedural success will be compared in both study groups. | During the index procedure | |
Secondary | Need for post-dilatation after initial OCT. | The frequency of post-dilatation will be compared in both study groups. | During the index procedure | |
Secondary | Scaffold apposition after post-dilatation. | The scaffold apposition after post-dilatation will be compared based on OCT assessment in both study groups. | During the index procedure | |
Secondary | Periprocedural complications: dissection, slow- or no flow, dissection requiring additional stent implantation. | The frequency of periprocedural complications as dissection, slow-flow, no flow and dissection requiring additional stent implantation will be compared separately in both study group. | During the index procedure | |
Secondary | Periprocedural myocardial infarction defined as 5x upper reference level elevation of high sensitive Troponin I (in patients with normal pre-procedural Troponin). | The frequency of periprocedural myocardial infarction will be compared in both study groups. | During the index procedure | |
Secondary | In-stent restenosis requiring revascularization within 12 months post-procedure. | The frequency of in-stent restenosis requiring revascularization will be compared in both study groups in 12 months follow-up. | 12 months after the index procedure | |
Secondary | Rate of stent thrombosis according the ARC (academic research consortium) criteria within 12 months post procedure. | The frequency of stent thrombosis will be compared in both study groups in 12 months follow-up. | 12 months after the index procedure | |
Secondary | Death or myocardial infarction within 12 months post procedure. | The frequency of death and myocardial infarction will be compared separately in both study groups in 12 months follow-up. | 12 months after the index procedure |
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