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First-in-human Evaluation of the SELUTION DCB, a Novel Sirolimus Coated Balloon in Peripheral Arteries

NCT02941224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-11-20

No results posted yet for this study

Summary

The primary objective of the Clinical Investigation is to assess the clinical safety and the inhibition of restenosis of the Investigational Device in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or popliteal arteries.

The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index procedure.

Conditions

  • Patients With Peripheral Artery Disease in the SFA or PA

Interventions

DEVICE

SELUTION DCB (sirolimus coated balloon)

Sponsors & Collaborators

  • M.A. Med Alliance S.A.

    lead INDUSTRY

Principal Investigators

  • Thomas Zeller, Prof Dr Med · Universitäts-Herzzentrum Freiburg-Bad Krozingen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-31
Completion
2019-09-30

Countries

  • Germany

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 NCT02941224 on ClinicalTrials.gov