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

NCT ID: NCT05868564

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2027-07-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Atherectomy+Drug-coated balloon

The lesion treated by atherectomy + UltrafreeTM drug-coated balloon.

Group Type: EXPERIMENTAL

Atherectomy+Drug-coated balloon

Intervention Type: DEVICE

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

Drug-coated balloon

The lesion treated by UltrafreeTM drug-coated balloon only.

Group Type: ACTIVE_COMPARATOR

Drug-coated balloon

Intervention Type: DEVICE

drug-coated balloon only in the active comparator group.

Interventions

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

Intervention Type: DEVICE

Drug-coated balloon

drug-coated balloon only in the active comparator group.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

Qingdao Hiser Medical Group

OTHER

Sponsor Role: collaborator

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng Ye, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Locations

Renji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Ni Qihong, M.D.

Role: CONTACT

niqihong1989@163.com

+8615801900772

Other Identifiers

The DEFINITIVE LL Study

Identifier Type: -

Identifier Source: org_study_id