Clinical trial NCT03521843: LDD in Treatment of Femoropopliteal ISR
Official title: Study of Local Drug Delivery in the Treatment of Femoropopliteal In-stent Restenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
In-stent Restenosis
Keywords: femoropopliteal occlusive disease
local drug delivery
endovascular treatment
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: target lesion revascularization
timeFrame: 12 months
Secondary outcomes:
measure: MLD
timeFrame: 6 months
measure: restenosis rate
timeFrame: 6 months
measure: adverse events
timeFrame: 12 months
measure: Rutherford level
timeFrame: 12 months
measure: ABI
timeFrame: 12 months
measure: main amputation
timeFrame: 12 months
measure: 12-month patency rate
timeFrame: 12 months
measure: 6-month patency rate
timeFrame: 6 months
measure: late lumen loss rate at secondary intervention
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: