Drug-coated BalloonPROMISINGNCT04826705
A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon
An observational study of Drug-coated Balloon and Femoropopliteal Artery Occlusion, run by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology at 9 sites in China.
Trial summary
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-coated Balloon, Femoropopliteal Artery Occlusion, Angioplasty
- What is being tested?
- Drug-coated Balloon
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 9 sitesChina
- Study dates
- 1 Feb 2021to 1 Feb 2027
- How long will I take part?
- 4 Years
- 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 femoralpopliteal artery occlusion.
Who may be able to join
- Rutherford grade 2-5.
- Femoral popliteal artery stenosis or occlusion, a clear outflow tract no less than 10cm long at the distal end of the knee should be continuous with a clear outflow tract under the ankle.
- Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
- The guide wire needs to pass through the lesion.
- Life expectancy> 24 months.
- Patients with thrombosis of the lower extremities, patients who received drug-coated balloon (DCB) intervention after thrombus removal through mechanical thrombus removal, percutaneous catheter thrombolysis, and thrombus removal.
Show all 9Show fewer
- Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
- There is at least one continuous infrapopliteal outflow artery or obtained through intravascular reconstruction.
- For combined aortic iliac artery disease, the blood flow can be recanalized after intravascular reconstruction without residual stenosis exceeding 50%.
Who cannot join
- Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
- Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
- Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
- Pregnant and lactating women.
- Patients who are unable or unwilling to participate in this trial.
- Patients with Berg's disease.
- Patients who have undergone arterial bypass on the treatment side.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Xuanwu Hospital Capital Medical University
Beijing
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu
Hangzhou First People's hospital of Medical College of Zhejiang University
Hangzhou
the First Affiliated hospital of Medicine College of Zhejiang University
Hangzhou
Qingdao Haici hospital affiliated to Qingdao University
Qingdao
Renji Hospital of Shanghai Jiaotong University
Shanghai
Zhongshan Hospital of Fudan University
Shanghai
the second Affiliated Hospital of Medical College of Suzhou University
Suzhou
Zibo Feng
Wuhan, Hubei, 430000
About this study
Official title: A Prospective, Multicenter, Observational Study of Short and Long-term Outcome in Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon (PROMISING Study)
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.
Read the detailed description
Traditional endovascular approaches to the treatment of atherosclerotic disease in the femoropopliteal arteries include percutaneous transluminal angioplasty (PTA) with an uncoated balloon and implantation of a bare metal stent. Recently, drug-eluting stents (DES) and drug-coated balloons (DCB) that transfer paclitaxel to the vessel wall during revascularization have been added to the suite of tools available to interventionists, helping to prevent restenosis after treatment.
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA).
Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB. It is estimated that 1200 patients with chronic femoral popliteal artery occlusion were enrolled in the group at 8 centers in China in two years. The follow-up would be conducted at 1, 3, 6, 12, 18, 24, 36 and 48 months after the operation to assess the efficacy and safety of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions.
- Being tested
- Drug-coated Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated BalloonDevice
To observe the effectiveness and safety of the drug-coated balloon in the treatment of lower extremity arteriosclerosis obliterans of the femoral popliteal artery segment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional
Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure baseline.
Measured: 48 months
Major adverse events
Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.
Measured: 48 months
Secondary outcomes (6)
Changes of the patency rate of target 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: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
Technical success rate
Successfully revascularize the target vessel. The residual stenosis is <30% and there is no acute thrombosis occurred in the target vessel within 1 week post-operation.
Measured: 1 week
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, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
The patient's ulcer healing
Ulcer healing in patients with Rutherford grade 5
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional
Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure baseline.
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Major adverse events
Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2027 (estimated)
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 Drug-coated BalloonStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Zhejiang University, Xuanwu Hospital, Beijing, First People's Hospital of Hangzhou, Second Affiliated Hospital of Suzhou University, Qingdao University, Chengdu University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Zibo Feng, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Zibo Feng, Principal investigator, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826705
- Sponsor's protocol ID
- the PROMISING Study
- Acronym
- PROMISING
- Status last verified
- Dec 2023
- First submitted
- 29 Mar 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Share data with multi-center participants in this study.
Publications
Li L, Zhu Y, Yang W, Du Y, Song Q, Wang T, Wang X, Li C, Chen Z, Feng Z. Endovascular Therapy for Femoropopliteal Artery Lesions Involving the Popliteal Artery: 1-Year Outcomes from a Real-World Multicenter Registry. Cardiovasc Intervent Radiol. 2026 Oct 13. doi: 10.1007/s00270-026-04638-6. Online ahead of print.
PubMed 42869965Li C, Zhu Y, Yang W, Du Y, Song Q, Wang T, Wang X, Li L, Feng Z. Impact of below-the-knee runoff in patients undergoing drug-coated balloon angioplasty for femoropopliteal disease: a propensity score-matched analysis. BMC Cardiovasc Disord. 2026 Jul 8. doi: 10.1186/s12872-026-06193-x. Online ahead of print.
PubMed 42420851
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study of Short and Long-term Outcome in Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon (PROMISING Study)
- ClinicalTrials.gov ID
- NCT04826705
- Acronym / sponsor ID
- PROMISING / the PROMISING Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- RenJi Hospital, Zhejiang University, Xuanwu Hospital, Beijing, First People's Hospital of Hangzhou, Second Affiliated Hospital of Suzhou University, Qingdao University, Chengdu University of Traditional Chinese Medicine
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 1 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.
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.
Detailed description
Traditional endovascular approaches to the treatment of atherosclerotic disease in the femoropopliteal arteries include percutaneous transluminal angioplasty (PTA) with an uncoated balloon and implantation of a bare metal stent. Recently, drug-eluting stents (DES) and drug-coated balloons (DCB) that transfer paclitaxel to the vessel wall during revascularization have been added to the suite of tools available to interventionists, helping to prevent restenosis after treatment.
There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA).
Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB. It is estimated that 1200 patients with chronic femoral popliteal artery occlusion were enrolled in the group at 8 centers in China in two years. The follow-up would be conducted at 1, 3, 6, 12, 18, 24, 36 and 48 months after the operation to assess the efficacy and safety of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with femoralpopliteal artery occlusion.
Key inclusion criteria (9 listed)
- Rutherford grade 2-5.
- Femoral popliteal artery stenosis or occlusion, a clear outflow tract no less than 10cm long at the distal end of the knee should be continuous with a clear outflow tract under the ankle.
- Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
- The guide wire needs to pass through the lesion.
- Life expectancy> 24 months.
Key exclusion criteria (7 listed)
- Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
- Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
- Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
- Pregnant and lactating women.
- Patients who are unable or unwilling to participate in this trial.
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 |
|---|---|---|
| Drug-coated BalloonTo observe the effectiveness and safety of the drug-coated balloon in the treatment of lower extremity arteriosclerosis obliterans of the femoral popliteal artery segment. | Device | – |
Primary outcome
Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional
Time frame: 48 months
Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure baseline.
Major adverse events
Time frame: 48 months
Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.
6 secondary outcomes
Changes of the patency rate of target lesions at post-interventional
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
Technical success rate
Time frame: 1 week
Vascular quality of life questionnaire(VascuQol)
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
The patient's ulcer healing
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months
Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Major adverse events
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months
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 5 Mar 2024.
- Derived from this study: PubMed 42869965Li L, Zhu Y, Yang W, Du Y, Song Q, Wang T, Wang X, Li C, Chen Z, Feng Z. Endovascular Therapy for Femoropopliteal Artery Lesions Involving the Popliteal Artery: 1-Year Outcomes from a Real-World Multicenter Registry. Cardiovasc Intervent Radiol. 2026 Oct 13. doi: 10.1007/s00270-026-04638-6. Online ahead of print.
- Derived from this study: PubMed 42420851Li C, Zhu Y, Yang W, Du Y, Song Q, Wang T, Wang X, Li L, Feng Z. Impact of below-the-knee runoff in patients undergoing drug-coated balloon angioplasty for femoropopliteal disease: a propensity score-matched analysis. BMC Cardiovasc Disord. 2026 Jul 8. doi: 10.1186/s12872-026-06193-x. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Share data with multi-center participants in this study.
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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.
Zibo Feng principal investigator
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-coated Balloon and Femoropopliteal Artery Occlusion, run by Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology at 9 sites 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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
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?
Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional (time frame: 48 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 NCT04826705, 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 5 Mar 2024.