Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions

Determination Of Effectiveness Of Directional Atherectomy Followed By A Paclitaxel- Coated Balloon For The Treatment Of Infrainguinal Vessels With Long Occlusive Femoropopliteal Lesions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Atherectomy+Drug-coated balloon; Device: Drug-coated balloon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ni Qihong, M.D.; Phone Number: +8615801900772; Email: niqihong1989@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • RenJi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atherectomy+Drug-coated balloon; The lesion treated by atherectomy + UltrafreeTM drug-coated balloon.	Device: Atherectomy+Drug-coated balloon; 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
Active Comparator: Drug-coated balloon; The lesion treated by UltrafreeTM drug-coated balloon only.	Device: Drug-coated balloon; drug-coated balloon only in the active comparator group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12-month
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	12-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after endovascular treatment
Procedural success	Defined as technical or device success without the occurrence of major adverse events	During the hospital stay
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	24-month
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.	24-month
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.	24-month

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Huashan Hospital; Xuanwu Hospital, Beijing; First Affiliated Hospital of Zhejiang University; Zhejiang University; Second Affiliated Hospital of Soochow University; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Affiliated Hospital of Nantong University; Qingdao Hiser Medical Group
• Investigators: Principal Investigator: Meng Ye, M.D., Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): July 31, 2027
• Study Completion (Anticipated): July 31, 2027

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: drug coated balloon; Atherectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: The DEFINITIVE LL Study

Drug and device information, study documents

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