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NOT YET RECRUITING
NCT04713865

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

Sponsor: Qingdao Hiser Medical Group

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2021-08-18

Completion Date

2026-08-17

Last Updated

2021-08-19

Healthy Volunteers

Not specified

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