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Multicentric Non-randomized Investigation of RESISTANT Camouflage Stent-system

NCT02011984 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2015-02-11

No results posted yet for this study

Summary

Non-randomized multicenter post-market study to confirm the long-term safety and effectiveness of the CE-approved Camouflage-coated self-expandable RESISTANT Camouflage stent system for revascularization of de novo stenotic lesions in the superficial femoral artery in 100 compliant patients suitable for stent angioplasty.

The CE-approved device will be used according to its intended use. Beyond the standard of care no further interventions are scheduled. Therefore, this trial is subject to the exception to the rule §23b of the German Medical Device Act (MPG), which includes the national implementation of EC directive 93/42/EEC.

Conditions

Sponsors & Collaborators

  • Eucatech AG

    lead INDUSTRY

Principal Investigators

  • Michael Giese, Phd · Eucatech AG

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-03-31
Completion
2017-02-28

Countries

  • Germany
  • Italy

Study Locations

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Entities

Diseases

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 NCT02011984 on ClinicalTrials.gov