Clinical trial NCT05868564: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Atherectomy
drug coated balloon
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Second Affiliated Hospital of Soochow University
name: Affiliated Hospital of Nantong University
name: First Affiliated Hospital of Zhejiang University
name: Zhejiang University
name: Qingdao Hiser Medical Group
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Huashan Hospital
First posted: 2023-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subject must be between 18 and 85 years old;
2. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 3-5;
3. 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;
4. Patent distal popliteal artery and at least one patent distal runoff;
5. Willing to comply with the follow-up evaluation;
6. Written informed consent prior to any study procedures.

Exclusion Criteria:

1. Women during pregnancy and lactation, or patients with baby planning;
2. Life expectancy\<2 years;
3. Target lesion/vessel with in-stent restenosis
4. Target restenosis/vessel lesion previously treated with drug coated balloon or atherectomy \<12 months
5. Subjects s who are currently participating in other interventional drug or device trials;
6. Angiographic evidence of thrombus within the target vessel
7. Subjects have a history of stroke within 3 months;
8. Subjects have a history of myocardial infarction, thrombolytic therapy, or angina pectoris within 2 weeks;
9. Concomitant Renal failure with a serum creatinine\>2.0mg/dl; Subjects with known allergy to heparin, low molecular weight heparin, and contrast agents.

Primary outcomes:
measure: Peak Systolic Velocity Ratio (PSVR)
timeFrame: 12-month
measure: Freedom from major adverse limb events（MALEs）
timeFrame: 12-month
Secondary outcomes:
measure: Technical success
timeFrame: Immediately after endovascular treatment
measure: Procedural success
timeFrame: During the hospital stay
measure: Primary sustained clinical improvement
timeFrame: 24-month
measure: Quality of life score
timeFrame: 24-month
measure: EuroQol five dimensions questionnaire (EQ 5D-5L) score
timeFrame: 24-month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Meng Ye, M.D.
role: PRINCIPAL_INVESTIGATOR
References: