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BIO REsponse Adapted Combination Therapy Pilot Study

NCT03547986 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-08-29

No results posted yet for this study

Summary

Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, due to a higher risk of blood clot formation, requiring a longer anticoagulant treatment, and the challenge of treating re growth of tissue extending through the metal mesh of the stent, the physicians try to reserve stent placement to situation where it's really needed, in case of flow-limiting vessel dissection or acute re-narrowing.

The purpose of this study is to evaluate the utility of several procedural diagnostic techniques in helping the physicians to better decide whether a stent is needed or not.

The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon associated to Pulsar 18 bare metal stent when and where needed to treat PAD

Conditions

  • Peripheral Arterial Disease

Interventions

DIAGNOSTIC_TEST

Duplex Ultrasound (DUS)

Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound

DIAGNOSTIC_TEST

IVUS with Intraarterial pressure measurement (IAP) if needed

Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Koen Deloose, MD · Sint Blasius Hospital Dendermonde, Belgium

  • Patrice Bibombe Mwipatayi, MD · Royal Perth Hospital

  • Michael Lichtenberg, MD · Clinic Arnsberg

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2022-01-03
Completion
2024-03-31

Countries

  • Australia
  • Austria
  • Belgium
  • France
  • Germany
  • Spain

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 NCT03547986 on ClinicalTrials.gov