search
Back to results

LDD in Treatment of Femoropopliteal ISR

Primary Purpose

Peripheral Artery Disease, In-stent Restenosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
balloon dilation only
balloon dilation+local drug delivery
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring femoropopliteal occlusive disease, local drug delivery, endovascular treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

balloon dilation only

balloon dilation+local drug delivery

Arm Description

The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.

The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.

Outcomes

Primary Outcome Measures

target lesion revascularization
the revascularization rate of target lesion

Secondary Outcome Measures

MLD
minimal lumen diameter of target vessel at 6 months
restenosis rate
the rate of re-stenosis (≥50) of target vessel at 6 months
adverse events
incidence of treatment related adverse events
Rutherford level
change of Rutherford level
ABI
change of ankle brachial index
main amputation
rate of main amputation
12-month patency rate
the 12-month patency rate of target vessel
6-month patency rate
the 6-month patency rate of target vessel
late lumen loss rate at secondary intervention
the rate of late lumen loss of target vessel at secondary intervention within 12 months

Full Information

First Posted
April 30, 2018
Last Updated
May 9, 2018
Sponsor
RenJi Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03521843
Brief Title
LDD in Treatment of Femoropopliteal ISR
Official Title
Study of Local Drug Delivery in the Treatment of Femoropopliteal In-stent Restenosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, In-stent Restenosis
Keywords
femoropopliteal occlusive disease, local drug delivery, endovascular treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
only the doctors know the group the patient goes into
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
balloon dilation only
Arm Type
Experimental
Arm Description
The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
Arm Title
balloon dilation+local drug delivery
Arm Type
Experimental
Arm Description
The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.
Intervention Type
Device
Intervention Name(s)
balloon dilation only
Intervention Description
The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
Intervention Type
Device
Intervention Name(s)
balloon dilation+local drug delivery
Intervention Description
The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.
Primary Outcome Measure Information:
Title
target lesion revascularization
Description
the revascularization rate of target lesion
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MLD
Description
minimal lumen diameter of target vessel at 6 months
Time Frame
6 months
Title
restenosis rate
Description
the rate of re-stenosis (≥50) of target vessel at 6 months
Time Frame
6 months
Title
adverse events
Description
incidence of treatment related adverse events
Time Frame
12 months
Title
Rutherford level
Description
change of Rutherford level
Time Frame
12 months
Title
ABI
Description
change of ankle brachial index
Time Frame
12 months
Title
main amputation
Description
rate of main amputation
Time Frame
12 months
Title
12-month patency rate
Description
the 12-month patency rate of target vessel
Time Frame
12 months
Title
6-month patency rate
Description
the 6-month patency rate of target vessel
Time Frame
6 months
Title
late lumen loss rate at secondary intervention
Description
the rate of late lumen loss of target vessel at secondary intervention within 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meng Ye, M.D., Ph.D.
Phone
+86 13817145123
Email
13817145123@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shuofei Yang, M.D., Ph.D.
Phone
+8613764227372
Email
doctor_yangshofei@163.com
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng Ye, M.D., Ph.D.
Phone
+86 13817145123
Email
13817145123@163.com

12. IPD Sharing Statement

Learn more about this trial

LDD in Treatment of Femoropopliteal ISR

We'll reach out to this number within 24 hrs