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Comparison of Paclitaxel-Coated Balloons Against Drug-Eluting Bioresorbable Scaffolds for Elective PCI Using OCT

NCT02607241 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-10-26

No results posted yet for this study

Summary

This prospective randomized clinical trial aims to compare two different "metal-free" strategies for elective percutaneous coronary revascularization: the FFR-guided DCB-only PCI (drug-coated balloon: SeQuent Please™, B Braun Melsungen GmBH) vs. OCT-guided BRS implantation (bioresorbable scaffold: Absorb™, Abbott Vascular).

Conditions

Interventions

DEVICE

OCT-guided BRS implantation

Implantation of a BRS using OCT to measure vessel size, choose BRS size and length and assess implantation results and the need of further postdilations

DEVICE

FFR-guided DCB-only PCI

PCI performed under FFR guidance using following algorithm: (1) predilation followed by angiographic assessment of residual stenosis and dissections; (2) evaluate suitability for DCB-only, which is deemed feasible if the FFR \> 0.8, residual diameter stenosis \< 40% and no flow-limiting dissections are observed; (3) DCB dilation and (4) assessment of final results using FFR and QCA measurements. Provisional stenting is allowed only if the final PCI results are not acceptable (flow-limiting dissection, residual stenosis \> 40% or FFR \< 0.8).

Sponsors & Collaborators

  • KKS Netzwerk

    collaborator NETWORK

  • University of Jena

    lead OTHER

Principal Investigators

  • Tudor C Poerner, MD · Jena University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-02-28
Completion
2018-10-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT02607241 on ClinicalTrials.gov