Clinical trial NCT05662618: To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Shanghai Bomaian Medical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: primary patency rate, PPR.
timeFrame: 12months
Secondary outcomes:
measure: Device success rate
timeFrame: The day of operation.
measure: Operation success rate
timeFrame: 1DAY
measure: Target Lesion Revascularization incidence.
timeFrame: 12 months after operation.
Other outcomes:
measure: Incidence rate of major adverse events
timeFrame: 12 months after operation.
measure: Occurrence of other adverse events and serious adverse events
timeFrame: 12 months after operation.
Locations:
city: Beijing
country: China
facility: The First Medical Center of the General Hospital of the Chinese People's Liberation Army
state: Beijing
Study officials:
References: