Femoropopliteal Occlusive DiseaseNCT04698304
The Efficacy of Endovascular Treatment in FPOD With TASC C and D Lesions
An observational study of Femoropopliteal Occlusive Disease, run by RenJi Hospital at 1 site in China.
Trial summary
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal Occlusive Disease
- What is being tested?
- endovascular treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1,518 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with TASC C, D femoropopliteal lesions who undergoing endovascular treatment
Who may be able to join
- Patients over 18 years old
- Patients with Rutherford classification range from 3 to 6
- If patients with both lower limbs meeting the inclusion criteria, both side of limb can be selected for this study
- The guide wire should pass through the lesion of femoropopliteal artery, and further endovascular treatment is performed. In this study, we did not limit the methods of the guide wire passing through the target lesion
- If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled
- For patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery
- Informed consent signed by patients
Who cannot join
- Patients who are unwilling or refuse to sign the informed consent form
- Patients with acute and subacute lower extremity arterial thrombosis or arterial embolism
- Patients with thromboangiitis obliterans
- Patients with failure of endovascular treatment, and transferred to bypass surgery
- Patients who underwent surgical atherectomy for common femoral artery occlusive lesions
- Patients with known allergy to heparin, low molecular weight heparin and contrast agents
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- Patients who have been enrolled in other clinical trials in the past 3 months
- Women during pregnancy and lactation
- Patients with other diseases that may lead to difficulties in the trial or significantly shorten the life expectancy (< 3 years), such as tumors, severe liver disease, cardiac insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physician-initiated, Prospective, Multi-center，Observational Study: The Efficacy of Endovascular Treatment in Femoropopliteal Occlusive Disease (FPOD) With TransAtlantic InterSociety Consensus (TASC) C and D Lesions
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
The TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.
Read the detailed description
According to the TASC II guidelines, TASC D lesions was recommended for primary endovascular revascularization, TASC C lesions for surgical revascularization in patients with appropriate perioperative risk and available conduit. However, Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
Despite The shift of Endovascular- first strategy has been documented in recent literature. There still lack evidence to support either approach have a significant advantage over the other. And TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.
- Conditions
- Femoropopliteal Occlusive Disease
- Being tested
- endovascular treatment
- Keywords
- Femoropopliteal Occlusive Disease, endovascular treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular treatmentProcedure or surgery
All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods according to the characteristics of the lesions. For example: (a) Plain old balloon angioplasty; (b) Drug-coated balloon angioplasty; (c) Drug-coated balloon angioplasty + provisional stenting; (d) Bare-metal stent implantation; (e) Stent graft implantation; (f) Directional atherectomy + drug-coated balloon angioplasty, (g) Drug -eluting stent.
| Study group | Role | What they receive |
|---|---|---|
| Group A：TASC C lesion group | Multiple stenoses or occlusions totaling >15cm or recurrent stenoses or occlusions that need treatment after endovascular interventions (300 cases) Receives: Procedure: endovascular treatment | |
| Group B：TASC D lesion with common femoral artery involved | Chronic total occlusions >20cm with common femoral artery involved (100 cases) Receives: Procedure: endovascular treatment | |
| Group C：TASC D lesion with proximal popliteal artery involved | Chronic total occlusions >20cm with proximal popliteal artery involved (300 cases) Receives: Procedure: endovascular treatment | |
| Group D：TASC D lesion with distal popliteal artery involved | Chronic total occlusions >20cm with distal popliteal artery involved (200 cases) Receives: Procedure: endovascular treatment | |
| Group E：TASC D lesion with popliteal artery and proximal trifurcation vessels involved | Chronic total occlusion of popliteal artery (P1-3 segment) with proximal trifurcation vessels involved (100 cases) Receives: Procedure: endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events (MAE)
major adverse events including major adverse limb events (MALE) or death
Measured: 24 months
Secondary outcomes (5)
Procedural success rate
Procedural success refers to 1. Establishment of continuous blood flow, no early occlusion, acute thrombosis or reintervention driven by target lesion within 7 days after operation
Measured: 7 days
Clinical-driven Target lesion reintervention rate
Target lesion reintervention rate
Measured: 24 months
Incidence of major adverse limb events (MALE)
Major adverse limb events (MALE) including clinically-driven target lesion revascularization (CD-TLR) and major amputation
Measured: 24 months
Incidence of major amputation
Major amputation defined as above-ankle amputation
Measured: 24 months
All-cause mortality
All-cause mortality defined as death from any cause
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Dec 2020
- Primary completion31 Dec 2025
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,518 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Second Affiliated Hospital of Suzhou University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital of Zhejiang University, Xiamen Cardiovascular Hospital, Xiamen University, Shanghai Zhongshan Hospital, Huashan Hospital, Qingdao Haici Hospital, First People's Hospital of Hangzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698304
- Sponsor's protocol ID
- The Oriental Study
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-initiated, Prospective, Multi-center，Observational Study: The Efficacy of Endovascular Treatment in Femoropopliteal Occlusive Disease (FPOD) With TransAtlantic InterSociety Consensus (TASC) C and D Lesions
- ClinicalTrials.gov ID
- NCT04698304
- Acronym / sponsor ID
- The Oriental Study
- Conditions
- Femoropopliteal Occlusive Disease
- Keywords
- Femoropopliteal Occlusive Disease, endovascular treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,518 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Second Affiliated Hospital of Suzhou University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital of Zhejiang University, Xiamen Cardiovascular Hospital, Xiamen University, Shanghai Zhongshan Hospital, Huashan Hospital, Qingdao Haici Hospital, First People's Hospital of Hangzhou
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 6 Jan 2021 (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.
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
The TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.
Detailed description
According to the TASC II guidelines, TASC D lesions was recommended for primary endovascular revascularization, TASC C lesions for surgical revascularization in patients with appropriate perioperative risk and available conduit. However, Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, more challenging femoropopliteal arterial lesions have been treated with endovascular procedures.
Despite The shift of Endovascular- first strategy has been documented in recent literature. There still lack evidence to support either approach have a significant advantage over the other. And TASC D lesion ,especially with popliteal artery involved are often excluded in prospective clinical trials. Therefore, a well-designed real world study that track clinical relevant outcomes, are required to determine the optimal therapies for patients with complex femoropopliteal lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A：TASC C lesion group | – | Procedure: endovascular treatmentMultiple stenoses or occlusions totaling >15cm or recurrent stenoses or occlusions that need treatment after endovascular interventions (300 cases) |
| Group B：TASC D lesion with common femoral artery involved | – | Procedure: endovascular treatmentChronic total occlusions >20cm with common femoral artery involved (100 cases) |
| Group C：TASC D lesion with proximal popliteal artery involved | – | Procedure: endovascular treatmentChronic total occlusions >20cm with proximal popliteal artery involved (300 cases) |
| Group D：TASC D lesion with distal popliteal artery involved | – | Procedure: endovascular treatmentChronic total occlusions >20cm with distal popliteal artery involved (200 cases) |
| Group E：TASC D lesion with popliteal artery and proximal trifurcation vessels involved | – | Procedure: endovascular treatmentChronic total occlusion of popliteal artery (P1-3 segment) with proximal trifurcation vessels involved (100 cases) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with TASC C, D femoropopliteal lesions who undergoing endovascular treatment
Key inclusion criteria (7 listed)
- Patients over 18 years old
- Patients with Rutherford classification range from 3 to 6
- If patients with both lower limbs meeting the inclusion criteria, both side of limb can be selected for this study
- The guide wire should pass through the lesion of femoropopliteal artery, and further endovascular treatment is performed. In this study, we did not limit the methods of the guide wire passing through the target lesion
- If the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled
Key exclusion criteria (9 listed)
- Patients who are unwilling or refuse to sign the informed consent form
- Patients with acute and subacute lower extremity arterial thrombosis or arterial embolism
- Patients with thromboangiitis obliterans
- Patients with failure of endovascular treatment, and transferred to bypass surgery
- Patients who underwent surgical atherectomy for common femoral artery occlusive lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular treatmentAll the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods according to the characteristics of the lesions. For example: (a) Plain old balloon angioplasty; (b) Drug-coated balloon angioplasty; (c) Drug-coated balloon angioplasty + provisional stenting; (d) Bare-metal stent implantation; (e) Stent graft implantation; (f) Directional atherectomy + drug-coated balloon angioplasty, (g) Drug -eluting stent. | Procedure or surgery | Group A：TASC C lesion group, Group B：TASC D lesion with common femoral artery involved, Group C：TASC D lesion with proximal popliteal artery involved, Group D：TASC D lesion with distal popliteal artery involved, Group E：TASC D lesion with popliteal artery and proximal trifurcation vessels involved |
Primary outcome
Incidence of major adverse events (MAE)
Time frame: 24 months
major adverse events including major adverse limb events (MALE) or death
5 secondary outcomes
Procedural success rate
Time frame: 7 days
Clinical-driven Target lesion reintervention rate
Time frame: 24 months
Incidence of major adverse limb events (MALE)
Time frame: 24 months
Incidence of major amputation
Time frame: 24 months
All-cause mortality
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Femoropopliteal Occlusive Disease, run by RenJi Hospital 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 17 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse events (MAE) (time frame: 24 months). 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 17 Sep 2026.