Back to resultsA Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
Primary Purpose
Peripheral Vascular Disease (PVD), Peripheral Arterial Disease (PAD)
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spot stent system
Self-expanding peripheral stent system
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease (PVD)
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years old and ≤80 years old
- Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
- Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
- Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
- Presence of at least one patent infrapopliteal vessel.
- The length of target lesion ≥10 cm.
- After predilation, the target lesion has <30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
- Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed.
Exclusion Criteria:
- The plasma creatinine level is higher than 150 umol/L.
- Thrombolysis or thrombectomy is required.
- The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
- Previously implanted stent in the target lesion.
- The guide wire can not cross the target lesion.
- Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable.
- Patient has a known allergy to anticoagulant drugs, anti-platelet drugs or contrast medium that cannot be adequately pre-medicated.
- Women who are pregnant or breast-feeding.
- The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
- Patient has life expectancy of less than 12 months.
- Patient who planned to do above the ankle amputation before the operation.
- Patient who had severe hemorrhage or coagulation disorder which judged by the investigator.
- The investigator think the patient is not suitable for participation in the clinical trial.
Sites / Locations
- Chinese PLA General HospitalRecruiting
- Zhejiang Provincial People'S HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Spot stent system
Self-Expanding peripheral stent system
Arm Description
A system that loaded multi low radial force stents on one catheter.
A conventional stent system that commonly used.
Outcomes
Primary Outcome Measures
The primary patency rate of target lesion at 12 months post-procedure
Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)
Secondary Outcome Measures
Rate of device success
Defined as successful delivery, release and retrieval of the device.
Rate of procedural success
Defined as no provisional stent implanted or major adverse event occured prior to discharge.
Rate of clinically driven target lesion revascularization within 12 months post-procedure
Defined as any reintervention at the target lesion due to the following symptoms: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI
The change of Rutherford class from baseline
Defined as change in target limb Rutherford class from baseline to 12 months
The change of ankle-brachial index (ABI) from baseline
Defined as change of target limb ABI from baseline to 12 months
Rate of composite safety endpoint
Defined a composite rate of all cause death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) through 30 days post- procedure
Full Information
NCT ID
NCT05246410
First Posted
February 8, 2022
Last Updated
November 10, 2022
Sponsor
Acotec Scientific Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05246410
Brief Title
A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
Official Title
A Prospective, Multicenter and Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Spot Stent System Using in the Percutaneous Transluminal Angioplasty of Femoropopliteal Arteries.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
November 28, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acotec Scientific Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
Detailed Description
The objective of this clinical investigation is to assess the efficacy and safety of spot stent system ,which is indicated for use in patients with atherosclerotic disease of the superficial femoral artery (SFA) or proximal popliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease (PVD), Peripheral Arterial Disease (PAD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spot stent system
Arm Type
Experimental
Arm Description
A system that loaded multi low radial force stents on one catheter.
Arm Title
Self-Expanding peripheral stent system
Arm Type
Active Comparator
Arm Description
A conventional stent system that commonly used.
Intervention Type
Device
Intervention Name(s)
Spot stent system
Intervention Description
Spot stent system designed and produced by Acotec
Intervention Type
Device
Intervention Name(s)
Self-expanding peripheral stent system
Intervention Description
Self-expanding peripheral stent system designed and produced by Ev3, Inc
Primary Outcome Measure Information:
Title
The primary patency rate of target lesion at 12 months post-procedure
Description
Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)
Time Frame
12 months post-procedure
Secondary Outcome Measure Information:
Title
Rate of device success
Description
Defined as successful delivery, release and retrieval of the device.
Time Frame
immediate post-procedure
Title
Rate of procedural success
Description
Defined as no provisional stent implanted or major adverse event occured prior to discharge.
Time Frame
7 days post-procedure
Title
Rate of clinically driven target lesion revascularization within 12 months post-procedure
Description
Defined as any reintervention at the target lesion due to the following symptoms: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI
Time Frame
12 months post-procedure
Title
The change of Rutherford class from baseline
Description
Defined as change in target limb Rutherford class from baseline to 12 months
Time Frame
12 months post-procedure
Title
The change of ankle-brachial index (ABI) from baseline
Description
Defined as change of target limb ABI from baseline to 12 months
Time Frame
12 months post-procedure
Title
Rate of composite safety endpoint
Description
Defined a composite rate of all cause death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) through 30 days post- procedure
Time Frame
30 days post-procedure
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:
Age ≥18 years old and ≤80 years old
Had lower extremity arterial occlusive diseases, and Rutherford classification is 2-5
Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee), located ≥1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal artery at the superior end of the patella.
Target lesion had severe stenosis (stenosis degree ≥70%) or occlusion.
Presence of at least one patent infrapopliteal vessel.
The length of target lesion ≥10 cm.
After predilation, the target lesion has <30% residual stenosis and presence of at least one flow-limiting dissection (by visual estimate).
Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed.
Exclusion Criteria:
The plasma creatinine level is higher than 150 umol/L.
Thrombolysis or thrombectomy is required.
The patient had underwent lower-limb arterial surgery or thrombolysis on the target limb within 6 weeks.
Previously implanted stent in the target lesion.
The guide wire can not cross the target lesion.
Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable.
Patient has a known allergy to anticoagulant drugs, anti-platelet drugs or contrast medium that cannot be adequately pre-medicated.
Women who are pregnant or breast-feeding.
The subjects have participated in other drug property studies or device studies that have not yet completed the main end point.
Patient has life expectancy of less than 12 months.
Patient who planned to do above the ankle amputation before the operation.
Patient who had severe hemorrhage or coagulation disorder which judged by the investigator.
The investigator think the patient is not suitable for participation in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo Wei, MD
Phone
010-66887329
Email
pla301dml@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo Wei, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Guo, MD
Phone
010-66887329
Email
pla301dml@vip.sina.com
Facility Name
Zhejiang Provincial People'S Hospital
City
Zhejiang
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsong Jiang
Email
jiangjinsong082022@126.com
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
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