Common Femoral Artery Occlusive DiseaseEAST-CFANCT05603546
A Prospective, Multicenter, Observational Study on the Treatment of Chronic Common Femoral Artery Bifurcation Occlusion
An observational study of Common Femoral Artery Occlusive Disease, run by Qingdao Hiser Medical Group at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Femoral Artery Occlusive Disease
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2022to 14 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hiser Medical Group
Qingdao, Shandong
qiang Li, 17669757601, liyu6588@163.com
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Major adverse events
Major adverse events at 30days
Measured: post-interventional 30days
freedom from target lesion revascularization
freedom from target lesion revascularization at 2years
Measured: post-interventional 2 years
Secondary outcomes (8)
Technical success rate
Measured: post-intervention
Time of surgery
Measured: post-intervention
Time of hospital stay
Measured: post-hospitalization
primary patency of CFA
primary patency of CFA at 1,3,6, 9,12 and 24 month
Measured: 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
Measured: 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
Measured: post-interventional 1,3,6, 9,12 month
Perioperative complications
Perioperative complications at 30days
Measured: post-interventional 30days
Direct and indirect medical expenditures associated with the disease
Direct and indirect medical expenditures associated with the disease at 24months
Measured: post-hospitalization 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start15 Feb 2022
- Primary completion14 Feb 2024 (estimated)
- Study completion14 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Femoral Artery Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Hiser Medical Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603546
- Sponsor's protocol ID
- the EAST-CFA study
- Acronym
- EAST-CFA
- Status last verified
- Jan 2022
- First submitted
- 13 Feb 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study on the Treatment of Chronic Common Femoral Artery Bifurcation Occlusion
- ClinicalTrials.gov ID
- NCT05603546
- Acronym / sponsor ID
- EAST-CFA / the EAST-CFA study
- Conditions
- Common Femoral Artery Occlusive Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qingdao Hiser Medical GroupUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 14 Feb 2024 (estimated)
- Study completion
- 14 Feb 2026 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFA treated by endarterectomy | – | –Common femoral artery lesions undergo endometrial decortication |
| CFA treated by transluminal extraction-atherectomy | – | –Common femoral artery lesions are treated intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse events
Time frame: post-interventional 30days
Major adverse events at 30days
freedom from target lesion revascularization
Time frame: post-interventional 2 years
freedom from target lesion revascularization at 2years
8 secondary outcomes
Technical success rate
Time frame: post-intervention
Time of surgery
Time frame: post-intervention
Time of hospital stay
Time frame: post-hospitalization
primary patency of CFA
Time frame: post-interventional 1,3,6, 9,12 and 24 month
primary patency of PFA
Time frame: post-interventional 1,3,6, 9,12 and 24 month
freedom from target lesion revascularization
Time frame: post-interventional 1,3,6, 9,12 month
Perioperative complications
Time frame: post-interventional 30days
Direct and indirect medical expenditures associated with the disease
Time frame: post-hospitalization 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Related trials for Common Femoral Artery Occlusive Disease
Active, not recruiting
A Study Evaluating the Endovascular Treatment of Subjects With Stenotic or Restenotic Lesions of the Common Femoral Artery With the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy
Peripheral Arterial Disease
RecruitingObservational study
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Femoral Arterial Calcification, Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Femoral Artery Occlusive Disease, run by Qingdao Hiser Medical Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact qiang Li (17669757601, liyu6588@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse events (time frame: post-interventional 30days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.