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

NCT03518645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-05-08

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.

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

OPN strategy

Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.

DEVICE

standard strategy

Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.

Sponsors & Collaborators

  • SIS Medical AG

    collaborator INDUSTRY

  • KCRI

    lead OTHER

Principal Investigators

  • Florim Cuculi, MD, PhD · Luzerner Kantonsspital

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
2016-12-31
Completion
2018-03-29

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 NCT03518645 on ClinicalTrials.gov