Femoropopliteal Artery Stenoses or Occlusive LesionsNCT07187128
A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.
A study testing drug coating balloon angioplasty in people with Femoropopliteal Artery Stenoses or Occlusive Lesions, run by BrosMed Medical Co., Ltd at 2 sites in China.
Trial summary
T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Femoropopliteal Artery Stenoses or Occlusive Lesions
- What is being tested?
- drug coating balloon angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 22 Sep 2025to 30 Dec 2028
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 85 years, gender not restricted;
- Rutherford grade 2 to 5
- Target lesions located in the superficial femoral artery (SFA) and/or proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics:
- Diameter stenosis ≥70% by visual estimation or
- Chronic total occlusion (CTO)
- At least one native below-the-knee artery supplying the foot on the affected side preoperatively;
- The guidewire can successfully pass through the target lesion site within the vascular lumen;
- Agree to participate in this clinical study and voluntarily sign the informed consent form.
Who cannot join
- Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment
- Type D or higher dissection occurring after target lesion predilation;
- Residual diameter stenosis >50% following target lesion predilation;
- Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;
- Abnormal function of vital organs (liver/kidney/brain) deemed unsuitable for intervention by investigators;
- Documented allergy to aspirin, clopidogrel, heparin, paclitaxel/structural analogs, or contrast agents;
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- Patients currently undergoing dialysis or immunosuppressive therapy;
- Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;
- History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;
- Pregnancy or lactation women;
- Currently participation in other drug/medical device clinical trials without completion;
- Patients deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Lianrui Guo, 010-83199270, Guolianrui@xwhosp.org
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chognqing
Fenghe Li, 023-89011876, Lifenghe@163.com
About this study
T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.
- Being tested
- drug coating balloon angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug coating balloon angioplastyDevice
The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions
| Study group | Role | What they receive |
|---|---|---|
| VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter | Experimental | Not described Receives: Device: drug coating balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency Rate at 12 months post-procedure
12-month primary patency of the target lesion is defined as: absence of clinically driven target lesion revascularization and no Doppler ultrasound-diagnosed target lesion restenosis within 12 months postoperatively. Doppler ultrasound-diagnosed restenosis refers to a peak systolic velocity ratio (PSVR) ≥2.4 at the target lesion (indicating ≥50% luminal stenosis).
Clinically Driven: Rutherford classification increase, ABI decrease, or imaging evidence of ≥70% stenosis.
Target Lesion Revascularization: Includes any endovascular or open procedure at the target lesion site (e.g., PTA, stent placement, bypass surgery, thrombectomy, thrombolysis) or major amputation of the target limb.
Measured: 12 months
Secondary outcomes (6)
Device Success Rate
Measured: Immediately after procedure
Primary Patency Rate at 24 months post-procedure
Measured: 24 months
Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure
Measured: 12 months; 24 months
Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively
Measured: 6, 12, 24 months
Change in ABI (ankle-brachial index) from baseline at 12 and 24 months postoperatively
Measured: 12, 24 months
MAEs Rates at 12 Months and 24 Months Post-Procedure
MAEs: Include all-cause mortality within 30 days post-procedure, amputation of the treated limb, and clinically driven target vessel revascularization (TVR).
Measured: 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start22 Sep 2025 (estimated)
- Primary completion10 Oct 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal Artery Stenoses or Occlusive LesionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrosMed Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187128
- Sponsor's protocol ID
- BM-MK01
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.
- ClinicalTrials.gov ID
- NCT07187128
- Acronym / sponsor ID
- BM-MK01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- BrosMed Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2025 (estimated)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 22 Sep 2025 (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.
T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter | Experimental | Device: drug coating balloon angioplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 85 years, gender not restricted;
- Rutherford grade 2 to 5
- Target lesions located in the superficial femoral artery (SFA) and/or proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics:
- At least one native below-the-knee artery supplying the foot on the affected side preoperatively;
- The guidewire can successfully pass through the target lesion site within the vascular lumen;
Key exclusion criteria (12 listed)
- Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment
- Type D or higher dissection occurring after target lesion predilation;
- Residual diameter stenosis >50% following target lesion predilation;
- Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;
- Abnormal function of vital organs (liver/kidney/brain) deemed unsuitable for intervention by investigators;
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 coating balloon angioplastyThe subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions | Device | VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter |
Primary outcome
Primary Patency Rate at 12 months post-procedure
Time frame: 12 months
12-month primary patency of the target lesion is defined as: absence of clinically driven target lesion revascularization and no Doppler ultrasound-diagnosed target lesion restenosis within 12 months postoperatively. Doppler ultrasound-diagnosed restenosis refers to a peak systolic velocity ratio (PSVR) ≥2.4 at the target lesion (indicating ≥50% luminal stenosis). Clinically Driven: Rutherford classification increase, ABI decrease, or imaging evidence of ≥70% stenosis. Target Lesion Revascularization: Includes any endovascular or open procedure at the target lesion site (e.g., PTA, stent placement, bypass surgery, thrombectomy, thrombolysis) or major amputation of the target limb.
6 secondary outcomes
Device Success Rate
Time frame: Immediately after procedure
Primary Patency Rate at 24 months post-procedure
Time frame: 24 months
Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure
Time frame: 12 months; 24 months
Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively
Time frame: 6, 12, 24 months
Change in ABI (ankle-brachial index) from baseline at 12 and 24 months postoperatively
Time frame: 12, 24 months
MAEs Rates at 12 Months and 24 Months Post-Procedure
Time frame: 12, 24 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 22 Sep 2025.
Related trials for Femoropopliteal Artery Stenoses or Occlusive Lesions
Not yet recruitingPhase 2/3
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Popliteal Artery Disease, Superficial Femoral Artery 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.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug coating balloon angioplasty in people with Femoropopliteal Artery Stenoses or Occlusive Lesions, run by BrosMed Medical Co., Ltd at 2 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 22 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 2 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency Rate at 12 months post-procedure (time frame: 12 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 22 Sep 2025.