To Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Percutaneous selective arteriography of peripheral arteries; Procedure: Percutaneous selective arteriography of peripheral arteries

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Guo; Phone Number: 010-66887329; Email: Pla301dml@vip.sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • The First Medical Center of the General Hospital of the Chinese People's Liberation Army
      • Contact: Wei Guo; Phone Number: 010-66887329; Email: Pla301dml@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	It is defined as: the balloon catheter can reach the target lesion, expand successfully, without rupture, and withdraw successfully.	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).	1DAY
Target Lesion Revascularization incidence.	Target Lesion Revascularization is defined as any re intervention treatment required in the target lesion.	12 months after operation.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of major adverse events	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	12 months after operation.
Occurrence of other adverse events and serious adverse events	Evaluation method: other adverse events and serious adverse events of the subjects were recorded through telephone/hospital visit.	12 months after operation.

Collaborators and Investigators

• Sponsor: Shanghai Bomaian Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): December 31, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: LFBMA-202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No