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

Not Applicable

Not yet recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Atherectomy+Drug-coated balloon; Device: Drug-coated balloon

• Registration Number: NCT05868564
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2023-03-07
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-19
• Last Update Submitted: 2023-05-19
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Study Start: 2023-07-01
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atherectomy+Drug-coated balloon	Atherectomy+Drug-coated balloon	The lesion treated by atherectomy + UltrafreeTM drug-coated balloon.
Drug-coated balloon	Drug-coated balloon	The lesion treated by UltrafreeTM drug-coated balloon only.

Primary Outcome Measures

Name	Time	Method
Peak Systolic Velocity Ratio (PSVR)	12-month	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）	12-month	Freedom from flow-limiting dissections (D-F), clinically-driven target vessel revascularization, major amputation, and all-cause of death

Secondary Outcome Measures

Name	Time	Method
EuroQol five dimensions questionnaire (EQ 5D-5L) score	24-month	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.
Procedural success	During the hospital stay	Defined as technical or device success without the occurrence of major adverse events
Technical success	Immediately after endovascular treatment	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.
Quality of life score	24-month	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.
Primary sustained clinical improvement	24-month	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

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China