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NCT Number: NCT04713865

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic atherosclerosis obliterans aged over 18 years
  • Patients presenting Rutherford classification from 2-5
  • Patients is willing to follow-up on time
  • Patient has a life expectancy of at least 24 months
  • Prior to enrolment, the guidewire has crossed target lesion
  • De novo lesions located in the femoral artery bifurcation (5mm between distal CFA and proximal SFA), need for primary bare metal stent implantation
  • There is a patent deep femoral artery demonstrated by angiography
  • If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled (9)For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery .

(10) The lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle, and at least one healthy dorsalis pedis artery, medial or lateral plantar artery connected with the digital artery below the ankle (11) Informed consent signed by patients

Exclusion criteria

  • Patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc.
  • In the past 3 months, they have participated in other drugs that interfere with this clinical trial or patients in clinical trials of medical devices
  • Pregnant and lactating women
  • Patients with other diseases that may make the trial difficult or significantly shorten the patient's life expectancy (<2 years), such as tumors, severe liver disease, cardiac insufficiency, etc or patients whose life expectancy is less than 24 months (24 months of follow-up are required)
  • Patients with acute arterial thrombosis or embolism at the target lesion site.
  • Patients who underwent stent implantation in common femoral artery previously

(8) Use of thrombectomy, atherectomy or laser devices during procedure (9) Previous open surgery in the same limb . (10) Patients with deep femoral artery totally occlusion

Treatment and study plan

endovascular treatment

Procedure

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

Primary outcomes

  1. Major adverse events and freedom from target lesion revascularization

    Time frame: post-interventional 48 months

    Major adverse events and freedom from target lesion revascularization at 48 months

Secondary outcomes

  1. primary patency of PFA and bare metal stent

    Time frame: post-interventional 1,6, 12,24,36 and 48 month

    primary patency of PFA and bare metal stent at 1,6, 12,24,36 and 48 month

  2. MAE

    Time frame: post-interventional 1,6, 12,24,36 month

    Major adverse events at 1,6, 12,24,36 month

  3. F -TLR

    Time frame: post-interventional 1,6, 12,24,36 month

    freedom from target lesion revascularization at 1,6, 12,24,36 month

Sponsors and collaborators

Lead sponsor

Qingdao Hiser Medical Group

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jan 19, 2021
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.