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Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions

NCT03129750 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2017-06-08

No results posted yet for this study

Summary

The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.

The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DCB currently available on the market.

Conditions

  • PAD

Interventions

DEVICE

Drug Coated Balloon

Peripheral PTA with a drug coated balloon

Sponsors & Collaborators

  • Ettore Sansavini Health Science Foundation

    lead OTHER

Principal Investigators

  • Antonio Micari, MD · Maria Cecilia Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-09-30
Completion
2020-09-30

Countries

  • Italy

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 NCT03129750 on ClinicalTrials.gov