A Prospective, Multicenter, Observational Study on the Treatment of Chronic Common Femoral Artery Bifurcation Occlusion

NCT05603546 | Recruiting

• 1 other identifier: the EAST-CFA study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, multicenter real-world observational study to understand the safety and efficacy of endoluminal therapy and traditional endometristomy in the real world for patients with severe stenosis and occlusion of the common femoral artery. The study will enroll 300 patients with severe stenosis and occlusion of chronic common femoral artery in nine centers across the country. According to the different intervention methods of the common femoral artery, the enrolled cases were divided into two groups: A: endometrial detachment for common femoral artery lesions and B: interventional endovascular treatment for common femoral artery lesions. As it is a real-world study, there is no separate primary endpoint indicator, which mainly observes F-TLR (immunity from vascular re-intervention), technical success rate, duration of surgery, length of hospital stay, common femoral artery patency rate, deep femoral artery patency rate, direct and indirect medical expenditure associated with the disease in 24 months, MAE (major adverse events), and perioperative complications.

Conditions

Common Femoral Artery Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• Major adverse events

  Major adverse events at 30days

  post-interventional 30days

• freedom from target lesion revascularization

  freedom from target lesion revascularization at 2years

  post-interventional 2 years

Secondary Outcomes (8)

• Technical success rate

  post-intervention

• Time of surgery

  post-intervention

• Time of hospital stay

  post-hospitalization

• primary patency of CFA

  post-interventional 1,3,6, 9,12 and 24 month

• primary patency of PFA

  post-interventional 1,3,6, 9,12 and 24 month

Study Arms (2)

CFA treated by endarterectomy

Common femoral artery lesions undergo endometrial decortication

CFA treated by transluminal extraction-atherectomy

Common femoral artery lesions are treated intravenously

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe chronic primary stenosis or occlusion of the common femoral artery (including the femoral artery bifurcation) requiring endovascular therapy or plaque stripping were enrolled

You may qualify if:

• Patients with chronic atherosclerotic occlusion who are over 18 years old;
• Patients with Rutherford clinical grading range in the range of 2-5;
• The stenosis rate of the common femoral artery (including the bifurcation of the femoral artery) is \> 60% or occlusive, and it is proposed to undergo intraluminal treatment such as balloon dilation, stent implantation, plaque rotation and excision, or endometrial decortication treatment;
• At least one healthy sub-knee outflow tract (or opened through reconstruction) communicates with the blood vessels of the foot;
• Intravascular treatment: the guide wire successfully passed through the target lesion;
• For patients with combined aorta iliac artery lesions, after completing the reconstruction of the main iliac artery, they can be enrolled according to the above requirements; except for the ipsilateral iliac artery, other non-target lesions of the remaining non-target blood vessels can be treated by the doctor at his own discretion;
• For patients with both lower limbs that meet the admission conditions, both limbs can be enrolled separately in chronological order;
• Written informed consent prior to the study procedure.

You may not qualify if:

• Patients who are unwilling or refuse to sign informed consent;
• Known or suspected allergy or contraindications to aspirin, clopidogrel bisulfate, heparin or contrast agents;
• Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 onths;
• pregnant and lactating women;
• Life expectancy is less than 24 months;
• Patients whose common femoral artery has received endometrial detachment, plaque rotation, stent implantation and restenosis in stents;
• Patients with acute ischemia of grade III lower extremities who have lost the opportunity for vascular reconstruction;
• Any major medical condition that the researchers believe may affect the subject's optimal participation in the study.

Sponsors & Collaborators

• Qingdao Hiser Medical Group: lead

Study Sites (1)

Hiser Medical Group

Qingdao, Shandong, China

RECRUITING

Central Study Contacts

qiang Li

CONTACT

17669757601; liyu6588@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: November 2, 2022
• Study Start: February 15, 2022
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2026
• Last Updated: November 2, 2022

Record last verified: 2022-01

Locations

CN (1)