Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease

Not Applicable

• Conditions: Peripheral Artery Disease; Endovascular Treatment
• Interventions: Device: drug-coated balloon dilation; Device: directional atherectomy and locol drug delivery

• Registration Number: NCT03380650
• Lead Sponsor: RenJi Hospital

Brief Summary

This study will evaluate the effectiveness and safety of directional atherectomy plus local drug delivery using balloon catheter system in the treatment of femoropopliteal occlusive disease. Patients of femoropopliteal occlusive disease will randomly receive directional atherectomy plus local drug delivery using balloon catheter system and dilation using drug-coated balloon. Their clinical outcomes (e.g. 12-month late lumen loss rate, 1-year patency rate of target vessel) in 1 year after the treatment will be compared.

Detailed Description

Femoropopliteal occlusive disease is a common type of peripheral arterial disease. Endovascular treatment has been the first-line treatment of femoropopliteal occlusive disease. However, the in-stent re-stenosis has been a major limitation of well long-term patency rate after stent implantation. The chronic inflammation induced by stenting could be a main reason of re-stenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices, such as paclitaxel-coated balloon dilation, directional atherectomy, are developed. Directional atherectomy can effectively remove the atherosclerosis plaque but leave the inflammatory reaction along the atherectomy route. Here, we propose the hypothesis that using local drug delivery with balloon system can relieve the inflammation induced by atherectomy. Therefore, 40 patients of femoropopliteal occlusive disease will be randomly allocated into the group "directional atherectomy+local drug delivery with balloon system" or "drug-coated balloon only". The 1-year patency rate, incidence of complications, imaging parameters will be compared between groups.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-20
• Last Update Submitted: 2017-12-20
• Study First Posted: 2017-12-21
• Last Update Posted: 2017-12-21
• Study Start: 2018-01-01
• Primary Completion: 2018-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age of 18-80 years old
• patients of femoropopliteal occlusive disease (Rutherford 2-4)
• length of lesion ≤ 20cm
• have signed the informed consent

Exclusion Criteria

• serum Cr > 150 umol/L
• patients with acute thrombosis
• received endovascular treatment for femoropopliteal disease in recent 6 months
• less than 1 run-off vessel
• allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
• pregnancy and lactation
• relatively easy bleeding
• malignancy or irreversible organ failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
durg-coated balloon dilation	drug-coated balloon dilation	The drug-coated balloon will be used to treat the femoropopliteal occlusion.
directional atherectomy and LDD	directional atherectomy and locol drug delivery	The directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion.

Primary Outcome Measures

Name	Time	Method
patency rate	12 months	the rate of patency of target vessel
late lumen loss rate	12 months	the rate of late lumen loss of target vessel

Secondary Outcome Measures

Name	Time	Method
Rutherford level	12 months	change of Rutherford level
incidence of complications	12 months	incidence of treatment induced major complications
adverse events	12 months	incidence of treatment related adverse events
re-stenosis rate	12 months	the rate of re-stenosis (≥50)
ABI	12 months	change of ankle brachial index
main amputation	12 months	rate of main amputation
MLD	12 months	minimal lumen diameter of target vessel at 6 months
clinical outcomes	12 months	rate of re-intervention of target vessel