To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rapamycin coated peripheral balloon catheter Rapamycin coated peripheral balloon catheter of Bomaian Company. |
Procedure: Percutaneous selective arteriography of peripheral arteries
Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
Procedure: 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.
|
| Active Comparator: Drug eluting peripheral balloon catheter Paclitaxel eluting balloon catheter |
Procedure: Percutaneous selective arteriography of peripheral arteries
Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- primary patency rate, PPR. [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.
Secondary Outcome Measures
- Device success rate [The day of operation.]
It is defined as: the balloon catheter can reach the target lesion, expand successfully, without rupture, and withdraw successfully.
- Operation success rate [1DAY]
The success of surgery was defined as: residual stenosis ≤ 50% (without salvage stent implantation) or ≤ 30% (with salvage stent implantation).
- Target Lesion Revascularization incidence. [12 months after operation.]
Target Lesion Revascularization is defined as any re intervention treatment required in the target lesion.
Other Outcome Measures
- Incidence rate of major adverse events [12 months after operation.]
Major adverse events were defined as: all cause death at 30 days, amputation of diseased limbs 12 months after operation, and clinically driven target vessel revascularization
- Occurrence of other adverse events and serious adverse events [12 months after operation.]
Evaluation method: other adverse events and serious adverse events of the subjects were recorded through telephone/hospital visit.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with arteriosclerosis obliterans of lower extremities, and Rutherford's rating is 2-5.
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Patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within P1 stage)
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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)
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Those who agree to participate in this clinical trial and sign the informed consent form Exclusion criteria：
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This operation is planned to intervene patients with bilateral lower limbs.
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Patients whose guide wire fails to pass through the target lesion.
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Patients whose target lesion is in stent restenosis (ISR).
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≥ 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).
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Patients with target lesions requiring rotary resection/laser therapy/thrombus aspiration for this treatment.
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Patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e. residual stenosis ≥ 30% after treatment).
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There is less than one unobstructed blood vessel under the knee of the target limb before operation (unobstructed is defined as visual stenosis<50%).
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Residual stenosis ≥ 30% after pre expansion of target lesion or severe (≥ Grade D) flow limiting dissection.
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Patients with obviously abnormal renal function (creatinine > 2.5mg/dL or 220umol/L) or undergoing dialysis.
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Patients with severe liver dysfunction who are judged by the researcher to be unsuitable for surgery.
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Patients with severe coagulation dysfunction or uncontrolled severe infection who are not suitable for surgery.
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Patients who have performed distal amputation (above metatarsal) on the affected or opposite limb in the past.
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Patients who received local or systemic thrombolytic therapy within 48 hours before surgery.
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Patients receiving vascular interventional therapy or surgical treatment on target limb within 30 days before operation.
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Patients known to be allergic to aspirin, clopidogrel, paclitaxel and rapamycin.
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Pregnant or lactating women and patients with family planning during the study
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Patients who are participating in clinical trials of other drugs or medical devices but are not included in the group.
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Patients with life expectancy less than 12 months
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Patients not suitable for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Medical Center of the General Hospital of the Chinese People's Liberation Army | Beijing | Beijing | China | 100039 |
Sponsors and Collaborators
- Shanghai Bomaian Medical Technology Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LFBMA-202201