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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05868564
• Other study ID #: The DEFINITIVE LL Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 31, 2027

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Ni Qihong, M.D.
• Phone: +8615801900772
• Email: niqihong1989[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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
• Drug-coated balloon
drug-coated balloon only in the active comparator group.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (9)

Lead Sponsor	Collaborator
RenJi Hospital	Affiliated Hospital of Nantong University, First Affiliated Hospital of Zhejiang University, Huashan Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Qingdao Hiser Medical Group, Second Affiliated Hospital of Soochow University, Xuanwu Hospital, Beijing, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Procedural success	Defined as technical or device success without the occurrence of major adverse events	During the hospital stay
Secondary	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
Secondary	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
Secondary	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