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

NCT02468960 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-10-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • SIS Medical AG

    lead INDUSTRY

Principal Investigators

  • Florim Cuculi, Prof. dr

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-02-28
Completion
2018-12-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468960 on ClinicalTrials.gov