Femoropopliteal Artery OcclusionNCT04675632

Impact of Tibial Run Off on Clinical Outcome of Endovascular Therapy in Femoropopliteal Lesions (TALENT Study)

An observational study of Femoropopliteal Artery Occlusion, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Femoropopliteal Artery Occlusion
What is being tested?: Endovascular Therapy
Type of treatment: Surgery or procedure
How many people: 1,200 participants
Where: 1 siteChina
Study dates: 4 Jan 2021to 30 Jun 2025
How long will I take part?: 2 Years
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Arteriosclerosis obliterans of lower extremities

Who may be able to join

1) Rutherford stages 2-5. 2) The femoral and popliteal artery as the target of the study has at least ≥70% stenosis or occlusion.
3) Whether it is a primary femoral and popliteal artery disease or in-stent restenosis, patients who received endovascular recanalization successfully (Residual stenosis <30% and no flow-limiting arterial dissection) can be enrolled in the group.
4) For the patients with both lower limbs to be treated, both limbs can be selected into the group.
5) Patients who failed the first treatment because the guide wire could not pass through the lesion can still be included in the group after successful endovascular interventional treatment.
6) Patients who understand the purpose of this research, volunteer to participate in the experiment, sign an informed consent form and are willing to be followed up can be included in the experiment.
7) For ipsilateral aortoiliac artery disease, patients with residual stenosis <30% can also be included in the group after intravascular reconstruction.

Who cannot join

1) Patients with acute arterial thrombosis. 2) Patients with serum creatinine level> 176μmol/L. 3) Patients with Rutherford stage 5 have foot infection grades of 2 and 3 in the preoperative WIFI (WIfI) classification.
4) Limbs that have been treated with the femoral and popliteal artery bypass surgery.
5) Patients who are known to be allergic or sensitive to contrast agents, heparin, aspirin (ASA), other anticoagulant or antiplatelet therapies, and/or paclitaxel.
6) Patients with bleeding constitution. 7) Pregnant and lactating women. 8) Patients with a history of myocardial infarction or unstable angina within 3 months.
9) Patients with a history of TIA or cerebral infarction within 3 months. 10) Patients with severe disease such as liver failure. 11) Patients with a life expectancy of less than 24 months. 12) Participating in other drug or device studies currently. 13) Patients with poor treatment compliance or deemed unsuitable for inclusion in the group by the researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

Chunshuihe
Chengdu, Sichuan, 610000

Other trials in China

About this study

Official title: the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine

This study is a prospective, multicenter, real world, observational study intended to understand the impact of tibial run off on clinical outcome of endovascular therapy in Femoropopliteal lesions. It is estimated that 1200 patients with chronic femoral popliteal artery occlusion were enrolled in the group at 8 centers nationwide from January 2021 to December 2022. Two groups would be divided according to whether or not the tibial run off intervened for reconstruction. The intervention group and the non-intervention group. The intervention group would be evaluated Run-off score again after the tibial run off reconstructed. The the Society for Vascular Surgery(SVS) run-off score would be used for the score of the tibial run off. The total score of the tibial run off would be 19 points, 1 point indicating healthy run off. According to the quality of the run off, the preoperative patients would be divided into 1-5, 6-10, 11-15, and >15 points. The follow-up would be conducted at 1, 6, 12, 18 and 24 months after the operation. As it is a real world study, there is no determined end point.The main indicators would be observed including the reintervention rate driven by lesions' clinical symptoms, the rate of primary patency of the femoral popliteal artery, the improvement of quality of life score and rutherford grading.

Read the detailed description

Arteriosclerosis obliterans of lower extremities (arteriosclerosis obliterans, ASO) is a common and frequently-occurring disease in middle-aged and elderly people, and also an important manifestation of atherosclerosis in lower extremities.ASO is reported to be present in approximately 12%-14% of the population, increasing to 20% of the population over the age of 75.The current treatment methods of ASO include pharmacotherapy, surgical procedures, endovascular treatment, combined surgery, and autologous peripheral blood stem cell transplantation (ASCT), etc.Endovascular treatment of ASO for lower limbs has the advantages of safety, effectiveness and fewer complications, and has become the preferred treatment for ASO.Endovascular treatment mainly includes: percutaneous transluminal angioplasty (PTA) and bare stent implantation. Currently, the most commonly used surgical options include: ordinary balloon dilatation + drug-coated balloon (DCB) dilatation + bare stent implantation.A number of studies have proved that DCB and bare stent are more effective than common PTA, but postoperative restenosis in ASO is always a difficulty.In addition to the chronic total occlusion or diffuse lesion of the lower extremity arteries, the inferior genicular artery outflow channel, age, diabetes, hemodialysis and critical limb ischemia are all related.Matsumi J, et al. found that patency of the inferior genicular artery may be an important predictor of adverse events after the SMART stent implantation in patients with popliteal artery disease, and the preservation of the distal outflow tract may be beneficial to reduce the rate of restenosis Early analysis of the patency rate of inferior genicular artery bypass found that poor outflow tract could lead to an increase in bypass thrombosis events.Matsumi J,et al. found that patency of the Early analysis of the patency rate of inferior genicular artery bypass found that poor outflow tract could lead to an increase in bypass thrombosis events. may be an important predictor of adverse events after SMART stent implantation in patients with popliteal artery disease, and the preservation of the distal outflow tract may be beneficial to reduce the rate of restenosis.Daniel M et al. conducted a retrospective analysis of 95 patients with femoral popliteal artery stent implantation and found that,for patients with poor subgenual artery outflow tract, the number of additional inferior genicular artery during femoral artery stent implantation usually leads to better clinical outcomes.the number of inferior genicular artery shown by preoperative angiography is an independent predictor of post-stent clinical outcomes.This study demonstrates the importance of distal outflow tract clinical outcomes after stent implantation.Yusuke W,et al. conducted a retrospective study on 199 patients with chronic popliteal artery occlusion and found that additional inferior genicular artery opening during stent implantation was beneficial to the patency rate of the stent and clinical results .However, the current analysis of the influence of the tibial run off on the femoral popliteal patency is mainly a retrospective study.

The purpose is to evaluate the patency of the tibial run off through a prospective multicenter observational real world study, whether it has an impact on the therapeutic effect after endovascular treatment in femoral popliteal artery , and whether one-stage reconstruction of the tibial run off can improve the postoperative patency rate of endovascular treatment.

Conditions: Femoropopliteal Artery Occlusion
Being tested: Endovascular Therapy
Keywords: femoropopliteal artery occlusion, run off score, endovascular therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endovascular TherapyProcedure or surgery
the most commonly used surgical options include: ordinary balloon dilatation， drug-coated balloon (DCB) dilatation and bare stent implantation.

Study groups in NCT04675632
Study group	Role	What they receive
The intervention group		the tibial run off would be treated through endovascular therapy Receives: Procedure: Endovascular Therapy
the non-intervention group		the tibial run off would not be treated through endovascular therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

the clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
Any reintervention within the target lesion due to symptoms or drop of ABI≥20% or >0.15 when compared to post-index procedure baseline ABI.
Measured: 24 months
Changes of the patency rate of target(Femoropopliteal) lesions at post-interventional
the patency rate of target(Femoropopliteal) lesions would be determined by vascular ultrasound,Restenosis would be diagnosed if the peak systolic velocity ratio(PSVR)≥2. 5.
Measured: baseline and 24 months

Secondary outcomes (4)

vascular quality of life questionnaire(VascuQol)
The VascuQol was designed as a questionnaire containing five domains: pain (4 items), symptoms (4 items), activities (8 items), social (2 items), and emotional (7 items) to evaluate Health related quality of life (HRQL). Every item has seven response options, with scores ranging from 1 to 7. A total score is the sum of all 25 item scores divided by 25.And both the total score as well as the domain scores range from 1 (worst HRQL) to 7 (best HRQL).The lower the value, the poorer the quality of life.
Measured: 1 month,6 months,12 months,18 months and 24 months
Wound,Ischemia,and foot infection(WIFI) classification system
The Wound, Ischemia, and foot Infection (WIfI) classification system was created to encompass demographic changes and expanding techniques of revascularization to perform meaningful analyses of outcomes in the treatment of the threatened limb,including wound,ischemia and foot infection.Each index was evaluated by very low,low,moderate and high,the very low represents no risk,the high reveals high risk of amputation.
Measured: 1 month,6 months,12 months,18 months and 24 months
Changes of rutherford grade
Rutherford classified Peripheral arterial disease(PAD) into acute and chronic limb ischemia, emphasizing that each presentation requires different treatment algorithms.The system was based on clinical symptoms and objective findings, including Doppler, arterial brachial indices (ABI), and pulse volume recordings.Rutherford's acute limb ischemia(ALI) classification divides an extremity into viable, threatened, or irreversibly damaged categories from 0-6,the lowest reveals no hemodynamically significant occlusive disease,the highest shows functional foot no longer salvageable.
Measured: 1 month,6 months,12 months,18 months and 24 months
Incidence of perioperative adverse events
To measure the safety of the whole procedure,adverse events including acute vascular event,major adverse events related to surgery(major amputation,death) wound be monitored.
Measured: 1 month,6 months,12 months,18 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 202130 Jun 2025

First posted19 Dec 2020
Study start4 Jan 2021
Primary completion30 Jun 2025
Study completion30 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Femoropopliteal Artery OcclusionStudies 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-control
Time perspective: Prospective
Enrolment: 1,200 participants (actual)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT04675632
Sponsor's protocol ID: ChengduUTCMvs2
Status last verified: Jul 2025
First submitted: 6 Dec 2020
Last updated: 3 Aug 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wang Y, Gan S, He C, Li Q, Shi W, Feng Z, Wu Z, Guo L, Zhang L, Ye M. Clinical outcome of endovascular therapy for femoropopliteal artery lesions in patients with intermittent claudication: Twenty-four-month outcomes from the TALENT registry. J Vasc Surg. 2026 Apr;83(4):1125-1135.e3. doi: 10.1016/j.jvs.2025.11.020. Epub 2025 Nov 21.
PubMed 41276094
Liu Y, Wang Q, Wu Z, Fen Z, Guo L, Li Q, Fang X, Sang H, Dai Y, He C, Ye M. A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol. Front Cardiovasc Med. 2022 Nov 16;9:1035659. doi: 10.3389/fcvm.2022.1035659. eCollection 2022.
PubMed 36465469

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
SELUTION4SFA Trial
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon

All Femoropopliteal Artery Occlusion trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov ID: NCT04675632
Acronym / sponsor ID: ChengduUTCMvs2
Conditions: Femoropopliteal Artery Occlusion
Keywords: femoropopliteal artery occlusion, run off score, endovascular therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 1,200 participants (actual)
Lead sponsor: Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
Study start: 4 Jan 2021 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 30 Jun 2025 (actual)
First posted: 19 Dec 2020 (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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 2 Years
Number of arms: 2

Arm	Type	Receives
The intervention group	–	Procedure: Endovascular Therapythe tibial run off would be treated through endovascular therapy
the non-intervention group	–	–the tibial run off would not be treated through endovascular therapy

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Arteriosclerosis obliterans of lower extremities

Key inclusion criteria (6 listed)

1) Rutherford stages 2-5. 2) The femoral and popliteal artery as the target of the study has at least ≥70% stenosis or occlusion.
3) Whether it is a primary femoral and popliteal artery disease or in-stent restenosis, patients who received endovascular recanalization successfully (Residual stenosis <30% and no flow-limiting arterial dissection) can be enrolled in the group.
4) For the patients with both lower limbs to be treated, both limbs can be selected into the group.
5) Patients who failed the first treatment because the guide wire could not pass through the lesion can still be included in the group after successful endovascular interventional treatment.
6) Patients who understand the purpose of this research, volunteer to participate in the experiment, sign an informed consent form and are willing to be followed up can be included in the experiment.

Key exclusion criteria (5 listed)

1) Patients with acute arterial thrombosis. 2) Patients with serum creatinine level> 176μmol/L. 3) Patients with Rutherford stage 5 have foot infection grades of 2 and 3 in the preoperative WIFI (WIfI) classification.
4) Limbs that have been treated with the femoral and popliteal artery bypass surgery.
5) Patients who are known to be allergic or sensitive to contrast agents, heparin, aspirin (ASA), other anticoagulant or antiplatelet therapies, and/or paclitaxel.
6) Patients with bleeding constitution. 7) Pregnant and lactating women. 8) Patients with a history of myocardial infarction or unstable angina within 3 months.
9) Patients with a history of TIA or cerebral infarction within 3 months. 10) Patients with severe disease such as liver failure. 11) Patients with a life expectancy of less than 24 months. 12) Participating in other drug or device studies currently. 13) Patients with poor treatment compliance or deemed unsuitable for inclusion in the group by the researcher.

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 Therapythe most commonly used surgical options include: ordinary balloon dilatation， drug-coated balloon (DCB) dilatation and bare stent implantation.	Procedure or surgery	The intervention group

Primary outcome

the clinically driven target lesion revascularization(CD-TLR) rate at post-interventional
Time frame: 24 months
Any reintervention within the target lesion due to symptoms or drop of ABI≥20% or >0.15 when compared to post-index procedure baseline ABI.
Changes of the patency rate of target(Femoropopliteal) lesions at post-interventional
Time frame: baseline and 24 months
the patency rate of target(Femoropopliteal) lesions would be determined by vascular ultrasound,Restenosis would be diagnosed if the peak systolic velocity ratio(PSVR)≥2. 5.

4 secondary outcomes

vascular quality of life questionnaire(VascuQol)
Time frame: 1 month,6 months,12 months,18 months and 24 months
Wound,Ischemia,and foot infection(WIFI) classification system
Time frame: 1 month,6 months,12 months,18 months and 24 months
Changes of rutherford grade
Time frame: 1 month,6 months,12 months,18 months and 24 months
Incidence of perioperative adverse events
Time frame: 1 month,6 months,12 months,18 months and 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 3 Aug 2025.
Derived from this study: PubMed 41276094Wang Y, Gan S, He C, Li Q, Shi W, Feng Z, Wu Z, Guo L, Zhang L, Ye M. Clinical outcome of endovascular therapy for femoropopliteal artery lesions in patients with intermittent claudication: Twenty-four-month outcomes from the TALENT registry. J Vasc Surg. 2026 Apr;83(4):1125-1135.e3. doi: 10.1016/j.jvs.2025.11.020. Epub 2025 Nov 21.
Derived from this study: PubMed 36465469Liu Y, Wang Q, Wu Z, Fen Z, Guo L, Li Q, Fang X, Sang H, Dai Y, He C, Ye M. A prospective, multicenter, real-world observational study evaluating the impact of tibial runoff on clinical outcomes after endovascular therapy for femoropopliteal lesions: Research protocol. Front Cardiovasc Med. 2022 Nov 16;9:1035659. doi: 10.3389/fcvm.2022.1035659. eCollection 2022.

Related trials for Femoropopliteal Artery Occlusion

Active, not recruiting
SELUTION4SFA Trial
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon

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.

Meng Ye, doctor principal investigator

RenJi Hospital

Ziheng Wu, doctor principal investigator

Zhejiang University

Lianrui Guo, doctor principal investigator

Xuanwu Hospital, Beijing

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 Artery Occlusion, run by Chengdu University of Traditional Chinese Medicine 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 6 inclusion and 5 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 3 Aug 2025. 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?

the clinically driven target lesion revascularization(CD-TLR) rate at post-interventional (time frame: 24 months). 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?

On the ClinicalTrials.gov record for NCT04675632, which also lists 2 linked publications.

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 3 Aug 2025.