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

Study of Combined Use of Directional Atherectomy and Local Drug Delivery With Balloon Catheter System in the Treatment of Femoropopliteal Occlusive Disease

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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
Other: durg-coated balloon dilation; The drug-coated balloon will be used to treat the femoropopliteal occlusion.	Device: drug-coated balloon dilation; use of drug-coated balloon dilation for the treatment of femoralpopliteal disease
Other: directional atherectomy and LDD; The directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion.	Device: directional atherectomy and locol drug delivery; combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late lumen loss rate	the rate of late lumen loss of target vessel	12 months
patency rate	the rate of patency of target vessel	6 months
patency rate	the rate of patency of target vessel	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Lan Zhang, M.D., Ph.D., Renji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: endovascular treatment; local drug delivery; femoropopliteal occlusive disease; directional atherectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 2017-092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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