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

Primary Purpose

Peripheral Arterial Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Percutaneous selective arteriography of peripheral arteries
Percutaneous selective arteriography of peripheral arteries
Sponsored by
Shanghai Bomaian Medical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Medical Center of the General Hospital of the Chinese People's Liberation Army

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rapamycin coated peripheral balloon catheter

Drug eluting peripheral balloon catheter

Arm Description

Rapamycin coated peripheral balloon catheter of Bomaian Company.

Paclitaxel eluting balloon catheter

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Device success rate
It is defined as: the balloon catheter can reach the target lesion, expand successfully, without rupture, and withdraw successfully.
Operation success rate
The success of surgery was defined as: residual stenosis ≤ 50% (without salvage stent implantation) or ≤ 30% (with salvage stent implantation).
Target Lesion Revascularization incidence.
Target Lesion Revascularization is defined as any re intervention treatment required in the target lesion.

Full Information

First Posted
December 1, 2022
Last Updated
December 14, 2022
Sponsor
Shanghai Bomaian Medical Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05662618
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 31, 2022 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Bomaian Medical Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rapamycin coated peripheral balloon catheter
Arm Type
Experimental
Arm Description
Rapamycin coated peripheral balloon catheter of Bomaian Company.
Arm Title
Drug eluting peripheral balloon catheter
Arm Type
Active Comparator
Arm Description
Paclitaxel eluting balloon catheter
Intervention Type
Procedure
Intervention Name(s)
Percutaneous selective arteriography of peripheral arteries
Intervention Description
Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous selective arteriography of peripheral arteries
Intervention Description
Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.
Primary Outcome Measure Information:
Title
primary patency rate, PPR.
Description
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.
Time Frame
12months
Secondary Outcome Measure Information:
Title
Device success rate
Description
It is defined as: the balloon catheter can reach the target lesion, expand successfully, without rupture, and withdraw successfully.
Time Frame
The day of operation.
Title
Operation success rate
Description
The success of surgery was defined as: residual stenosis ≤ 50% (without salvage stent implantation) or ≤ 30% (with salvage stent implantation).
Time Frame
1DAY
Title
Target Lesion Revascularization incidence.
Description
Target Lesion Revascularization is defined as any re intervention treatment required in the target lesion.
Time Frame
12 months after operation.
Other Pre-specified Outcome Measures:
Title
Incidence rate of major adverse events
Description
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
Time Frame
12 months after operation.
Title
Occurrence of other adverse events and serious adverse events
Description
Evaluation method: other adverse events and serious adverse events of the subjects were recorded through telephone/hospital visit.
Time Frame
12 months after operation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Guo
Phone
010-66887329
Email
Pla301dml@vip.sina.com
Facility Information:
Facility Name
The First Medical Center of the General Hospital of the Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo
Phone
010-66887329
Email
Pla301dml@vip.sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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