To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
NCT ID: NCT05662618
Last Updated: 2022-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
276 participants
INTERVENTIONAL
2022-12-31
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rapamycin coated peripheral balloon catheter
Rapamycin coated peripheral balloon catheter of Bomaian Company.
Percutaneous selective arteriography of peripheral arteries
Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
Percutaneous selective arteriography of peripheral arteries
Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.
Drug eluting peripheral balloon catheter
Paclitaxel eluting balloon catheter
Percutaneous selective arteriography of peripheral arteries
Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
Percutaneous selective arteriography of peripheral arteries
Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.
Interventions
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Percutaneous selective arteriography of peripheral arteries
Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
Percutaneous selective arteriography of peripheral arteries
Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Patients whose guide wire fails to pass through the target lesion.
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Bomaian Medical Technology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The First Medical Center of the General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wei Guo
Role: primary
Other Identifiers
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LFBMA-202201
Identifier Type: -
Identifier Source: org_study_id