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The Acute and Long-term Clinical Outcome of Self- Expandable Stent in Complex Proximal Superficial Femoral Artery Lesions Involving the Femoral Bifurcation

NCT04713865 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2021-08-19

No results posted yet for this study

Summary

The stent-FP study investigates the impact of coverage of profound femoral artery (PFA) by bare metal stent deployed in proximal superficial femoral artery (SFA) lesions. 300 patients with femoral bifurcation lesions will be included and divided into 3 groups according to the location of proximal stent edge. The primary endpoint of the study is major adverse events and freedom from target lesion revascularization at 48 months. Secondary endpoints include primary patency of PFA and bare metal stent at 1,6, 12,24,36and 48 month, MAE and F -TLR at 1,6, 12,24,36 month.

Conditions

  • Common Femoral Artery Occlusive Disease

Interventions

PROCEDURE

endovascular treatment

The bare metal stent covers the deep femoral artery lower than 50%

PROCEDURE

endovascular treatment

The bare metal stent covers the deep femoral artery in 50-90%

PROCEDURE

endovascular treatment

The bare metal stent totally covers the deep femoral artery

Sponsors & Collaborators

  • Qingdao Hiser Medical Group

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2023-08-17
Completion
2026-08-17

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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 NCT04713865 on ClinicalTrials.gov