Peripheral Arterial DiseaseNCT05662618
To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
A study testing Percutaneous selective arteriography of peripheral arteries in people with Peripheral Arterial Disease, run by Shanghai Bomaian Medical Technology Co., Ltd at 1 site in China.
Trial summary
A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Percutaneous selective arteriography of peripheral arteries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2022to 30 Jun 2025
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with arteriosclerosis obliterans of lower extremities, and Rutherford's rating is 2-5.
- Patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within P1 stage)
- Patients with total length of target lesion ≤ 20cm and length of occluded segment ≤ 15cm (the distance between two segments of lesions less than 2cm is considered as the same lesion)
- Those who agree to participate in this clinical trial and sign the informed consent form Exclusion criteria：
- This operation is planned to intervene patients with bilateral lower limbs.
- Patients whose guide wire fails to pass through the target lesion.
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- Patients whose target lesion is in stent restenosis (ISR).
- ≥ 2 lesions need to be treated in the target vessel (if the distance between two lesions is less than 2cm, it is considered as the same lesion).
- Patients with target lesions requiring rotary resection/laser therapy/thrombus aspiration for this treatment.
- Patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e. residual stenosis ≥ 30% after treatment).
- There is less than one unobstructed blood vessel under the knee of the target limb before operation (unobstructed is defined as visual stenosis<50%).
- Residual stenosis ≥ 30% after pre expansion of target lesion or severe (≥ Grade D) flow limiting dissection.
- Patients with obviously abnormal renal function (creatinine > 2.5mg/dL or 220umol/L) or undergoing dialysis.
- Patients with severe liver dysfunction who are judged by the researcher to be unsuitable for surgery.
- Patients with severe coagulation dysfunction or uncontrolled severe infection who are not suitable for surgery.
- Patients who have performed distal amputation (above metatarsal) on the affected or opposite limb in the past.
- Patients who received local or systemic thrombolytic therapy within 48 hours before surgery.
- Patients receiving vascular interventional therapy or surgical treatment on target limb within 30 days before operation.
- Patients known to be allergic to aspirin, clopidogrel, paclitaxel and rapamycin.
- Pregnant or lactating women and patients with family planning during the study
- Patients who are participating in clinical trials of other drugs or medical devices but are not included in the group.
- Patients with life expectancy less than 12 months
- Patients not suitable for this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Medical Center of the General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, 100039
Wei Guo, 010-66887329, Pla301dml@vip.sina.com
About this study
Official title: Prospective, Multicenter, Randomized Controlled Clinical Trial to Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Percutaneous selective arteriography of peripheral arteries
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous selective arteriography of peripheral arteriesProcedure or surgery
Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
Percutaneous selective arteriography of peripheral arteriesProcedure or surgery
Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin coated peripheral balloon catheter | Experimental | Rapamycin coated peripheral balloon catheter of Bomaian Company. Receives: Procedure: Percutaneous selective arteriography of peripheral arteries |
| Drug eluting peripheral balloon catheter | Active comparator | Paclitaxel eluting balloon catheter Receives: Procedure: Percutaneous selective arteriography of peripheral arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency rate, PPR.
It is defined as:Primary patency of target lesion: the target lesion is patency (systolic peak blood flow ratio<2.4) and there is no clinically driven target lesion revascularization (TLR) by Doppler ultrasound.
Measured: 12months
Secondary outcomes (3)
Device success rate
It is defined as: the balloon catheter can reach the target lesion, expand successfully, without rupture, and withdraw successfully.
Measured: The day of operation.
Operation success rate
The success of surgery was defined as: residual stenosis ≤ 50% (without salvage stent implantation) or ≤ 30% (with salvage stent implantation).
Measured: 1DAY
Target Lesion Revascularization incidence.
Target Lesion Revascularization is defined as any re intervention treatment required in the target lesion.
Measured: 12 months after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start31 Dec 2022 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662618
- Sponsor's protocol ID
- LFBMA-202201
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Clinical Trial to Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
- ClinicalTrials.gov ID
- NCT05662618
- Acronym / sponsor ID
- LFBMA-202201
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Shanghai Bomaian Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Dec 2022 (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.
A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapamycin coated peripheral balloon catheter | Experimental | Procedure: Percutaneous selective arteriography of peripheral arteriesRapamycin coated peripheral balloon catheter of Bomaian Company. |
| Drug eluting peripheral balloon catheter | Active comparator | Procedure: Percutaneous selective arteriography of peripheral arteriesPaclitaxel eluting balloon catheter |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients with arteriosclerosis obliterans of lower extremities, and Rutherford's rating is 2-5.
- Patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within P1 stage)
- Patients with total length of target lesion ≤ 20cm and length of occluded segment ≤ 15cm (the distance between two segments of lesions less than 2cm is considered as the same lesion)
- Those who agree to participate in this clinical trial and sign the informed consent form Exclusion criteria：
- This operation is planned to intervene patients with bilateral lower limbs.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Percutaneous selective arteriography of peripheral arteriesTreatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter. | Procedure or surgery | Drug eluting peripheral balloon catheter, Rapamycin coated peripheral balloon catheter |
| Percutaneous selective arteriography of peripheral arteriesPaclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery. | Procedure or surgery | Drug eluting peripheral balloon catheter, Rapamycin coated peripheral balloon catheter |
Primary outcome
primary patency rate, PPR.
Time frame: 12months
It is defined as:Primary patency of target lesion: the target lesion is patency (systolic peak blood flow ratio<2.4) and there is no clinically driven target lesion revascularization (TLR) by Doppler ultrasound.
3 secondary outcomes
Device success rate
Time frame: The day of operation.
Operation success rate
Time frame: 1DAY
Target Lesion Revascularization incidence.
Time frame: 12 months after operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous selective arteriography of peripheral arteries in people with Peripheral Arterial Disease, run by Shanghai Bomaian Medical Technology Co., Ltd 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 23 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Guo (010-66887329, Pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary patency rate, PPR. (time frame: 12months). 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 Dec 2022.