Thromboembolic DiseaseNCT04861506
The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
An observational study of Thromboembolic Disease and Lower Extremity Problem, run by First People's Hospital of Hangzhou 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 and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb were treated with endovascular procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolic Disease, Lower Extremity Problem, Endovascular Treatment
- What is being tested?
- endovascular treatment
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.
Who may be able to join
- Patients aged 18 years or older.
- Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb.
- Rutherford classification ranging from 3 to 5.
- Successful guidewire passage through the lesion of the femoropopliteal artery lesion, followed by further endovascular treatment. There are no restrictions will be implemented on the methods used for guidewire passage through the target lesion. The presence of thrombus must be confirmed via angiography and/or DSA and must be associated with occlusions of the lower extremity or ISR.
- Mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT) and/or percutaneous aspiration thrombectomy(PAT) and/or CDT (catheter-directed thrombolysis) performed for thrombus removal.
- The lower extremity artery must have a healthy runoff of at least 10 cm above the ankle with at least one healthy dorsalis pedis artery, medial plantar artery, or lateral plantar artery connecting to the digital artery below the ankle.
- Informed consent signed by patients.
Who cannot join
- Acute or subacute limb ischemia patients with Rutherford classification stage III.
- Patients diagnosed with thromboangiitis obliterans.
- Patients requring open surgery or hybrid operation after contrast radiography.
- Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months.
- Patients with known allergies to heparin, low molecular weight heparin, or contrast agents.
- Patients at high risk for bleeding.
Show all 11Show fewer
- Pregnant or lactating women.
- Patients with other conditions that may complicate study participation or significantly reduce life expectancy (< 2 years), such as tumors, severe liver disease, and cardiac insufficiency.
- Patients enrolled in other clinical studies within the past 3 months.
- Patients unwilling or refusing to sign the informed consent form.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fan xin
Hangzhou, Zhejiang, 310006
xin fang, master, +08613867478324, hzfhfx@126.com
About this study
Official title: Physician-initiated, Prospective, Multi-center, Observational Study: The Safety and Efficiency Result of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, More and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb were treated with endovascular procedures. Most guidelines suggests only stage I and stage IIa lesions are suitable for endovascular treatments. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
Read the detailed description
According to the Trans-Atlantic Inter-Society Consensus (TASC) II guidelines, acute arterial occlusion which in stage IIb was recommended for thrombectomy. However, with the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, stage IIb patients and some subacute thromboembolic lesions were also effective in some retrospective studies.
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 thrombectomy. And stage IIb lesions and subacute lesions are often excluded in prospective clinical trials. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
- Conditions
- Thromboembolic Disease, Lower Extremity Problem, Endovascular Treatment, Safety Issues, Efficacy, Self
- Being tested
- endovascular treatment
- Medical subject headings
- Thromboembolism
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 such as pharmacomechanical thrombectomy (PMT) and mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT）and/or percutaneous aspiration thrombectom (PAT) and/or CDT(catheter-directed thrombolysis) and/or percutaneous aspiration thrombectom (PAT) thrombolysis (CDT) for thrombus removal according to the characteristics of the lesions and hospital conditions.
| Study group | Role | What they receive |
|---|---|---|
| acute or subacute thromboembolic occlusions of lower extremity | The patients are confirmed with acute or subacute thromboembolic occlusions of lower extremity, and which 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 such as mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT）and/or percutaneous aspiration thrombectom (PAT) and/or CDT(catheter-directed thrombolysis) and/or percutaneous aspiration thrombectom (PAT) for thrombus removal according to the characteristics of the lesions and hospital conditions. Receives: Procedure: endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation-free survival
The amputation-free survival after endovascular surgery
Measured: post-interventional 12months
Adverse events at post-interventional 1months
the incidence of amputation, operation-related distal embolism, rethrombosis, acute renal failure and/or death.
Measured: post-interventional 1 months
Secondary outcomes (7)
Technical success rate
Technical success rate
Measured: Post operation up to 1 day
Clinical-driven Target lesion reintervention(CD-TLR) rate
Clinical-driven Target lesion reintervention rate
Measured: post-interventional 12 months
Clinical-driven Target vascular reintervention(CD-TVR) rate
Clinical-driven Target vascular reintervention rate
Measured: post-interventional 12 months
The total time used in the operation
The total time used in the operation
Measured: Intraoperative
Primary patency(PP)of the lesions
Primary patency(PP)of the lesions
Measured: post-interventional 12 months
Changes of quality of life assessed by VascuQol scale
Changes of quality of life
Measured: post-interventional 12 months
Direct medical expenses (2-year cumulative hospitalization expenses and endovascular expenses related to target lesions)
Direct medical expenses
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thromboembolic 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 only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, First Affiliated Hospital of Zhejiang University, Xuanwu Hospital, Beijing, Qingdao Haici Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Second Affiliated Hospital of Suzhou University, Chengdu University of Traditional Chinese Medicine, Shanghai Zhongshan Hospital
- Responsible party
- Principal investigator, Fangxin, Hangzhou Cancer Hospital
- Investigators
- Meng Ye, Principal investigator, RenJi HospitalZiheng Wu, Principal investigator, First Affiliated Hospital of Zhejiang UniversityLianrui Guo, Principal investigator, Xuanwu Hospital, BeijingQiang Li, Principal investigator, Qingdao Haici HospitalZibo Feng, Principal investigator, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and TechnologyHongfei Sang, Principal investigator, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and TechnologyChunshui He, Principal investigator, Chengdu University of Traditional Chinese MedicineZhenyu Shi, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861506
- Sponsor's protocol ID
- The Resolve Study
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Long J, Wang L, Huang C, Xie X, Liu Y, Chen Y, Liu H, Ni Q, Yang S, Wu Z, Guo L, Feng Z, Li Q, He C, Sang H, Shi Z, Ye M, Fang X. Design of the RESOLVE study: a prospective, multicentre, observational, cohort study evaluating the safety and efficacy of endovascular treatment for acute or subacute thromboembolic occlusions of the lower extremity in China. BMJ Open. 2025 Oct 14;15(10):e103283. doi: 10.1136/bmjopen-2025-103283.
PubMed 41087108
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician-initiated, Prospective, Multi-center, Observational Study: The Safety and Efficiency Result of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
- ClinicalTrials.gov ID
- NCT04861506
- Acronym / sponsor ID
- The Resolve Study
- Conditions
- Thromboembolic Disease, Lower Extremity Problem, Endovascular Treatment, Safety Issues, Efficacy, Self
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- RenJi Hospital, First Affiliated Hospital of Zhejiang University, Xuanwu Hospital, Beijing, Qingdao Haici Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Second Affiliated Hospital of Suzhou University, Chengdu University of Traditional Chinese Medicine, Shanghai Zhongshan Hospital
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Apr 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 and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb were treated with endovascular procedures. Most guidelines suggests only stage I and stage IIa lesions are suitable for endovascular treatments. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
Detailed description
According to the Trans-Atlantic Inter-Society Consensus (TASC) II guidelines, acute arterial occlusion which in stage IIb was recommended for thrombectomy. However, with the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, stage IIb patients and some subacute thromboembolic lesions were also effective in some retrospective studies.
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 thrombectomy. And stage IIb lesions and subacute lesions are often excluded in prospective clinical trials. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute or subacute thromboembolic occlusions of lower extremity | – | Procedure: endovascular treatmentThe patients are confirmed with acute or subacute thromboembolic occlusions of lower extremity, and which 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 such as mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT）and/or percutaneous aspiration thrombectom (PAT) and/or CDT(catheter-directed thrombolysis) and/or percutaneous aspiration thrombectom (PAT) for thrombus removal according to the characteristics of the lesions and hospital conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute or subacute thromboembolic occlusions of lower extremity who undergoing endovascular treatment.
Key inclusion criteria (7 listed)
- Patients aged 18 years or older.
- Diagnosis of acute or subacute limb ischemia classified as Rutherford classification stage I to IIb.
- Rutherford classification ranging from 3 to 5.
- Successful guidewire passage through the lesion of the femoropopliteal artery lesion, followed by further endovascular treatment. There are no restrictions will be implemented on the methods used for guidewire passage through the target lesion. The presence of thrombus must be confirmed via angiography and/or DSA and must be associated with occlusions of the lower extremity or ISR.
- Mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT) and/or percutaneous aspiration thrombectomy(PAT) and/or CDT (catheter-directed thrombolysis) performed for thrombus removal.
Key exclusion criteria (11 listed)
- Acute or subacute limb ischemia patients with Rutherford classification stage III.
- Patients diagnosed with thromboangiitis obliterans.
- Patients requring open surgery or hybrid operation after contrast radiography.
- Patients with a history of stroke, cerebral hemorrhage, gastrointestinal bleeding, myocardial infarction, or similar conditions in the past 3 months.
- Patients with known allergies to heparin, low molecular weight heparin, or contrast agents.
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 such as pharmacomechanical thrombectomy (PMT) and mechanical thrombectomy device (MTD) and/or pharmacomechanical thrombectomy (PMT）and/or percutaneous aspiration thrombectom (PAT) and/or CDT(catheter-directed thrombolysis) and/or percutaneous aspiration thrombectom (PAT) thrombolysis (CDT) for thrombus removal according to the characteristics of the lesions and hospital conditions. | Procedure or surgery | acute or subacute thromboembolic occlusions of lower extremity |
Primary outcome
Amputation-free survival
Time frame: post-interventional 12months
The amputation-free survival after endovascular surgery
Adverse events at post-interventional 1months
Time frame: post-interventional 1 months
the incidence of amputation, operation-related distal embolism, rethrombosis, acute renal failure and/or death.
7 secondary outcomes
Technical success rate
Time frame: Post operation up to 1 day
Clinical-driven Target lesion reintervention(CD-TLR) rate
Time frame: post-interventional 12 months
Clinical-driven Target vascular reintervention(CD-TVR) rate
Time frame: post-interventional 12 months
The total time used in the operation
Time frame: Intraoperative
Primary patency(PP)of the lesions
Time frame: post-interventional 12 months
Changes of quality of life assessed by VascuQol scale
Time frame: post-interventional 12 months
Direct medical expenses (2-year cumulative hospitalization expenses and endovascular expenses related to target lesions)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 41087108Long J, Wang L, Huang C, Xie X, Liu Y, Chen Y, Liu H, Ni Q, Yang S, Wu Z, Guo L, Feng Z, Li Q, He C, Sang H, Shi Z, Ye M, Fang X. Design of the RESOLVE study: a prospective, multicentre, observational, cohort study evaluating the safety and efficacy of endovascular treatment for acute or subacute thromboembolic occlusions of the lower extremity in China. BMJ Open. 2025 Oct 14;15(10):e103283. doi: 10.1136/bmjopen-2025-103283.
- Individual participant dataSharing planned: No
Related trials for Thromboembolic Disease
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
Meng Ye principal investigator
RenJi Hospital
Ziheng Wu principal investigator
First Affiliated Hospital of Zhejiang University
Lianrui Guo 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 Thromboembolic Disease and Lower Extremity Problem, run by First People's Hospital of Hangzhou 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 11 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: looking for participants now, as of the sponsor's last update on 15 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xin Fang (+08613867478324, hzfhfx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation-free survival (time frame: post-interventional 12months). 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 NCT04861506, which also lists 1 linked publication.
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 15 Sep 2025.