Coronary Artery Disease Clinical Trial
Official title:
Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study
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.
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 (non-compliant) 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)
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