Back to resultsAtherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
Primary Purpose
Peripheral Arterial Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Atherectomy+Drug-coated balloon
Drug-coated balloon
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Atherectomy, drug coated balloon
Eligibility Criteria
Inclusion Criteria: Subject must be between 18 and 85 years old; Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5; Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(>70% diameter stenosis) >15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization; Patent distal popliteal artery and at least one patent distal runoff; Willing to comply with the follow-up evaluation; Written informed consent prior to any study procedures. Exclusion Criteria: Women during pregnancy and lactation, or patients with baby planning; Life expectancy<2 years; Target lesion/vessel with in-stent restenosis Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy <12 months Subjects s who are currently participating in other interventional drug or device trials; Angiographic evidence of thrombus within the target vessel Subjects have a history of stroke within 3 months; Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks; Concomitant Renal failure with a serum creatinine>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Atherectomy+Drug-coated balloon
Drug-coated balloon
Arm Description
The lesion treated by atherectomy + UltrafreeTM drug-coated balloon.
The lesion treated by UltrafreeTM drug-coated balloon only.
Outcomes
Primary Outcome Measures
Peak Systolic Velocity Ratio (PSVR)
Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion)
Freedom from major adverse limb events（MALEs）
Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death
Secondary Outcome Measures
Technical success
Defined as achievement of final residual diameter stenosis of <30% on the procedural completion angiogram, using the assigned device only, whereas lesion success is defined as achievement of <30% residual stenosis using any percutaneous method.
Procedural success
Defined as technical or device success without the occurrence of major adverse events
Primary sustained clinical improvement
Defined as sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients
Quality of life score
Quality of Life (QOL) score at 24 months; The minimum value is 1, and the maximum value is 7. The higher scores mean a better outcome.
EuroQol five dimensions questionnaire (EQ 5D-5L) score
EQ 5D-5L score at 24 months；The minimum value is 0, and the maximum value is 5. The higher scores mean a worse outcome.
Full Information
NCT ID
NCT05868564
First Posted
March 7, 2023
Last Updated
May 19, 2023
Sponsor
RenJi Hospital
Collaborators
Xuanwu Hospital, Beijing, Second Affiliated Hospital of Soochow University, Affiliated Hospital of Nantong University, First Affiliated Hospital of Zhejiang University, Zhejiang University, Qingdao Hiser Medical Group, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05868564
Brief Title
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
Official Title
Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Xuanwu Hospital, Beijing, Second Affiliated Hospital of Soochow University, Affiliated Hospital of Nantong University, First Affiliated Hospital of Zhejiang University, Zhejiang University, Qingdao Hiser Medical Group, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital
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
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.
Detailed Description
This is a multicenter, prospective, randomized, controlled comparison study. A total of 100 subjects will be enrolled into this study and will be randomized on a 1:1 basis to either drug coated balloon angioplasty combined with atherectomy or drug coated balloon angioplasty for subjects with long de-nove or restenosis femoropopliteal lesions( Stenotic lesion>15cm or Chronic total occlusion between 6-15cm). Angiographic patterns of the target lesion, including lesion length, calcification grade, and minimal lumen diameter (MLD) prior to and after the intervention, ultrasound images of the target lesion at 12-month follow-up will be independently adjudicated by an independent angiographic and ultrasound core lab. The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. Follow-up visits are scheduled at 1,3,6,12,24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Atherectomy, drug coated balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atherectomy+Drug-coated balloon
Arm Type
Experimental
Arm Description
The lesion treated by atherectomy + UltrafreeTM drug-coated balloon.
Arm Title
Drug-coated balloon
Arm Type
Active Comparator
Arm Description
The lesion treated by UltrafreeTM drug-coated balloon only.
Intervention Type
Device
Intervention Name(s)
Atherectomy+Drug-coated balloon
Intervention Description
Patients in experimental group will undergo endovascular treatment for femoropopliteal lesions. The lesion will be treated by atherectomy+drug-coated balloon in the experimental group
Intervention Type
Device
Intervention Name(s)
Drug-coated balloon
Intervention Description
drug-coated balloon only in the active comparator group.
Primary Outcome Measure Information:
Title
Peak Systolic Velocity Ratio (PSVR)
Description
Peak Systolic Velocity Ratio (PSVR) of target lesion measured by ultrasound (PSVR ≤2.4 means primary patent of target lesion)
Time Frame
12-month
Title
Freedom from major adverse limb events（MALEs）
Description
Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death
Time Frame
12-month
Secondary Outcome Measure Information:
Title
Technical success
Description
Defined as achievement of final residual diameter stenosis of <30% on the procedural completion angiogram, using the assigned device only, whereas lesion success is defined as achievement of <30% residual stenosis using any percutaneous method.
Time Frame
Immediately after endovascular treatment
Title
Procedural success
Description
Defined as technical or device success without the occurrence of major adverse events
Time Frame
During the hospital stay
Title
Primary sustained clinical improvement
Description
Defined as sustained upward shift of at least one category on the Rutherford classification without the need for repeated target lesion revascularization (TLR) in surviving patients
Time Frame
24-month
Title
Quality of life score
Description
Quality of Life (QOL) score at 24 months; The minimum value is 1, and the maximum value is 7. The higher scores mean a better outcome.
Time Frame
24-month
Title
EuroQol five dimensions questionnaire (EQ 5D-5L) score
Description
EQ 5D-5L score at 24 months；The minimum value is 0, and the maximum value is 5. The higher scores mean a worse outcome.
Time Frame
24-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be between 18 and 85 years old;
Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
Stenotic, restenosis, or occlusive lesions in the native femoropopliteal artery which meets all of the following criteria: Stenotic lesion(>70% diameter stenosis) >15cm or Chronic total occlusion between 6-15cm; Target vessel is 3.0 to 7.0 mm in diameter (visual estimate); Guidewire must be across the target lesion within the true lumen before study randomization;
Patent distal popliteal artery and at least one patent distal runoff;
Willing to comply with the follow-up evaluation;
Written informed consent prior to any study procedures.
Exclusion Criteria:
Women during pregnancy and lactation, or patients with baby planning;
Life expectancy<2 years;
Target lesion/vessel with in-stent restenosis
Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy <12 months
Subjects s who are currently participating in other interventional drug or device trials;
Angiographic evidence of thrombus within the target vessel
Subjects have a history of stroke within 3 months;
Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;
Concomitant Renal failure with a serum creatinine>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ni Qihong, M.D.
Phone
+8615801900772
Email
niqihong1989@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Ye, M.D.
Organizational Affiliation
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Learn more about this trial
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
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