Clinical trial NCT03380650: Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease
Official title: Study of Combined Use of Directional Atherectomy and Local Drug Delivery With Balloon Catheter System in the Treatment of Femoropopliteal Occlusive Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Endovascular Treatment
Keywords: femoropopliteal occlusive disease
directional atherectomy
local drug delivery
endovascular treatment
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-12-21
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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: late lumen loss rate
timeFrame: 12 months
measure: patency rate
timeFrame: 6 months
measure: patency rate
timeFrame: 12 months
Secondary outcomes:
measure: MLD
timeFrame: 12 months
measure: clinical outcomes
timeFrame: 12 months
measure: incidence of complications
timeFrame: 12 months
measure: re-stenosis rate
timeFrame: 12 months
measure: adverse events
timeFrame: 12 months
measure: Rutherford level
timeFrame: 12 months
measure: ABI
timeFrame: 12 months
measure: main amputation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Lan Zhang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: