LDD in Treatment of Femoropopliteal ISR

Study of Local Drug Delivery in the Treatment of Femoropopliteal In-stent Restenosis

This study will evaluate the effectiveness and safety of local drug delivery using TAPAS balloon catheter system in the treatment of femoropopliteal in-stent restenosis. Patients with femoropopliteal in-stent restenosis will randomly receive balloon dilation or balloon dilation plus local drug delivery using balloon catheter system. Their clinical outcomes (e.g. 12-month late lumen loss or late lumen loss at secondary intervention within 12 months, 6-month and 1-year patency rate of target vessel) in 1 year after the treatment will be compared.

Study Overview

• Status: Unknown
• Conditions: Peripheral Artery Disease; In-stent Restenosis
• Intervention / Treatment: Device: balloon dilation only; Device: balloon dilation+local 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 after stent implantation. The chronic inflammation induced by stenting could be a main reason of restenosis. Then the concept "leave nothing behind" is proposed, and some novel treatment methods and devices are developed. Here, the investigators propose the hypothesis that using local drug delivery with TAPAS balloon system can relieve the inflammation induced by the stent implantation and balloon dilation. Therefore, 40 patients of femoropopliteal in-stent restenosis will be randomly allocated into the group "balloon dilation+local drug delivery with balloon system" or "balloon dilation only". The 1-year patency rate,12-month late lumen loss, incidence of complications, imaging parameters will be compared between two groups.

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

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • RenJi Hospital
      • Contact: Meng Ye, M.D., Ph.D.; Phone Number: +86 13817145123; Email: 13817145123@163.com

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:

• have signed the informed consent
• age of 18-80 years old
• femoropopliteal artery disease (Rutherford 2-4)
• femoropopliteal in-stent restenosis (≥70%)
• length of lesion ≤ 20cm
• at least one infrapopliteal run-off vessel

Exclusion Criteria:

• serum Cr > 150 umol/L
• patients with acute thrombosis
• stent fracture within femoropopliteal artery
• allergic to aspirin, heparin, clopidogrel, paclitaxel, contrast medium
• already recruited into other clinical trials that could influence the outcome of this study
• 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
Experimental: balloon dilation only; The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.	Device: balloon dilation only; The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
Experimental: balloon dilation+local drug delivery; The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.	Device: balloon dilation+local drug delivery; The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target lesion revascularization	the revascularization rate of target lesion	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
MLD	minimal lumen diameter of target vessel at 6 months	6 months
restenosis rate	the rate of re-stenosis (≥50) of target vessel at 6 months	6 months
12-month patency rate	the 12-month patency rate of target vessel	12 months
6-month patency rate	the 6-month patency rate of target vessel	6 months
late lumen loss rate at secondary intervention	the rate of late lumen loss of target vessel at secondary intervention within 12 months	12 months

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): October 31, 2019

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: endovascular treatment; local drug delivery; femoropopliteal occlusive disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 12345678

Drug and device information, study documents

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