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"All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC for flOw liMiting Outcomes

NCT02531230 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2018-10-10

No results posted yet for this study

Summary

The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA) and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2 \& P3)

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

DEVICE

VascuFlex Multi-LOC®

Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty

Sponsors & Collaborators

  • Deaconess Hospital Mannheim

    collaborator OTHER

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Klaus Amendt, MD · Deaconess Hospital Mannheim

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-07-31
Completion
2017-08-31

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 NCT02531230 on ClinicalTrials.gov