NCT02468960

Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)

Optimal Lesion Preparation With Non-compliant Balloons for the Implantation of Bioresorbable Vascular Scaffolds (BVS) -OPRENBIS Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: SIS Medical AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Coronary Artery Disease
• Angina
• Unstable Angina
• Stable Angina

Interventions

Type	Name	Description
DEVICE	Predilatation with OPN NC balloon catheter.	Target lesion will be prepared by predilatation with OPN NC balloon catheter.
DEVICE	Predilatation with standard compliant balloon.	Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
DEVICE	Absorb BVS implantation.	After lesion preparation implantation of BVS Absorb scaffold will be performed.
PROCEDURE	Treated segment visualization by OCT.	Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
OTHER	Clinical FU at 12 months.	All patients will be clinically followed for 12 months.

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-02-01
• Completion: 2018-12-01
• First posted: 2015-06-11
• Last updated: 2017-10-31

Locations

1 site across 1 country: Switzerland