Observational study on treating chronic common femoral artery occlusion

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

This study is testing two different treatment methods for people with blocked femoral arteries to see which one is safer and works better.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qingdao Hiser Medical Group (Academic / other)
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT05603546 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety and efficacy of two treatment methods for chronic common femoral artery occlusion: endoluminal therapy and traditional endometristomy. It will enroll 300 patients across nine medical centers, focusing on those with severe stenosis or occlusion. Participants will be divided into two groups based on the intervention method, and the study will monitor various outcomes such as technical success rates and hospital stay duration without a predefined primary endpoint.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with chronic atherosclerotic occlusion and significant stenosis of the common femoral artery.

Not a fit: Patients with less than 60% stenosis or those not requiring intraluminal treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective treatment options for patients with chronic common femoral artery occlusion.

How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating treatment efficacy for vascular conditions.

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.

Where this trial is running

Qingdao, Shandong

• Hiser Medical Group — Qingdao, Shandong, China (Recruiting)

Study contacts

• Study coordinator: qiang Li

Conditions Common Femoral Artery Occlusive Disease