Clinical trial NCT05603546: A Prospective, Multicenter, Observational Study on the Treatment of Chronic Common Femoral Artery Bifurcation Occlusion
Official title: A Prospective, Multicenter, Observational Study on the Treatment of Chronic Common Femoral Artery Bifurcation Occlusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Common Femoral Artery Occlusive Disease
Lead sponsor: Qingdao Hiser Medical Group
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse events
timeFrame: post-interventional 30days
measure: freedom from target lesion revascularization
timeFrame: post-interventional 2 years
Secondary outcomes:
measure: Technical success rate
timeFrame: post-intervention
measure: Time of surgery
timeFrame: post-intervention
measure: Time of hospital stay
timeFrame: post-hospitalization
measure: primary patency of CFA
timeFrame: post-interventional 1,3,6, 9,12 and 24 month
measure: primary patency of PFA
timeFrame: post-interventional 1,3,6, 9,12 and 24 month
measure: freedom from target lesion revascularization
timeFrame: post-interventional 1,3,6, 9,12 month
measure: Perioperative complications
timeFrame: post-interventional 30days
measure: Direct and indirect medical expenditures associated with the disease
timeFrame: post-hospitalization 24 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Hiser Medical Group
state: Shandong
Study officials:
References: