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The DESappear Study: Drug Eluting Scaffold

NCT02869087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-06-01

No results posted yet for this study

Summary

The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA).

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

Akesys Prava Scaffold

Implantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • Massachusetts General Hospital

    collaborator OTHER

  • Genae

    collaborator INDUSTRY

  • Elixir Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Marc Bosiers, Doctor · AZ Sint-Blasius Dendermonde

  • Dierk Scheinert, Doctor · Universitätsklinikum Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-10
Primary Completion
2018-08-28
Completion
2021-04-30

Countries

  • Austria
  • Belgium
  • Germany
  • New Zealand

Study Locations

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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 NCT02869087 on ClinicalTrials.gov