LDD in Treatment of Femoropopliteal ISR

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03521843
• Other study ID #: 12345678
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: April 2018
• Source: RenJi Hospital
• Contact: Meng Ye, M.D., Ph.D.
• Phone: +86 13817145123
• Email: 13817145123[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• In-stent Restenosis
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• balloon dilation only
The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
• balloon dilation+local drug delivery
The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target lesion revascularization	the revascularization rate of target lesion	12 months
Secondary	MLD	minimal lumen diameter of target vessel at 6 months	6 months
Secondary	restenosis rate	the rate of re-stenosis (=50) of target vessel at 6 months	6 months
Secondary	adverse events	incidence of treatment related adverse events	12 months
Secondary	Rutherford level	change of Rutherford level	12 months
Secondary	ABI	change of ankle brachial index	12 months
Secondary	main amputation	rate of main amputation	12 months
Secondary	12-month patency rate	the 12-month patency rate of target vessel	12 months
Secondary	6-month patency rate	the 6-month patency rate of target vessel	6 months
Secondary	late lumen loss rate at secondary intervention	the rate of late lumen loss of target vessel at secondary intervention within 12 months	12 months