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Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

NCT03020290 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 335

Last updated 2021-09-09

No results posted yet for this study

Summary

Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).

The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criteria, the possible influence of calcifications and the quality of life of patients.

The SuperA stent treatment is not specifically provided for by the Protocol but is carried out within the framework of the care. This study is an observationnal study.

Conditions

  • Atherosclerosis Obliterans

Interventions

DEVICE

Endovascular treatment for PAD during medical care (SuperA stent (Abbott))

Long femoropopliteal stenting with SuperA devices during medical care. The endovascular treatment for PAD will be done during the usual medical treatment of patient. The intervention is not carried out within the framework of the research protocol

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Nantes University Hospital

    lead OTHER

Principal Investigators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-04-10
Completion
2018-04-10

Countries

  • France

Study Locations

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Entities

Companies

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 NCT03020290 on ClinicalTrials.gov