A Prospective, Multicenter, Observational Study on the Treatment of Chronic Common Femoral Artery Bifurcation Occlusion (EAST-CFA)

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.

Study Overview

• Status: Recruiting
• Conditions: Common Femoral Artery Occlusive Disease

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: qiang Li; Phone Number: 17669757601; Email: liyu6588@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China
      • Recruiting
      • Hiser Medical Group
      • Contact: qiang Li; Phone Number: 17669757601; Email: liyu6588@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

1. Patients with chronic atherosclerotic occlusion who are over 18 years old;
2. Patients with Rutherford clinical grading range in the range of 2-5;
3. 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;
4. At least one healthy sub-knee outflow tract (or opened through reconstruction) communicates with the blood vessels of the foot;
5. Intravascular treatment: the guide wire successfully passed through the target lesion;
6. 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;
7. For patients with both lower limbs that meet the admission conditions, both limbs can be enrolled separately in chronological order;
8. Written informed consent prior to the study procedure.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CFA treated by endarterectomy; Common femoral artery lesions undergo endometrial decortication
CFA treated by transluminal extraction-atherectomy; Common femoral artery lesions are treated intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate		post-intervention
Time of surgery		post-intervention
Time of hospital stay		post-hospitalization
primary patency of CFA	primary patency of CFA at 1,3,6, 9,12 and 24 month	post-interventional 1,3,6, 9,12 and 24 month
primary patency of PFA	primary patency of CFA at 1,3,6, 9,12 and 24 month	post-interventional 1,3,6, 9,12 and 24 month
freedom from target lesion revascularization	freedom from target lesion revascularization at 1,3,6, 9,12 month	post-interventional 1,3,6, 9,12 month
Perioperative complications	Perioperative complications at 30days	post-interventional 30days
Direct and indirect medical expenditures associated with the disease	Direct and indirect medical expenditures associated with the disease at 24months	post-hospitalization 24 months

Collaborators and Investigators

• Sponsor: Qingdao Hiser Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Anticipated): February 14, 2024
• Study Completion (Anticipated): February 14, 2026

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: October 30, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: the EAST-CFA study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No