Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease

Peripheral Artery Disease Clinical Trial

Official title:

Study of Combined Use of Directional Atherectomy and Local Drug Delivery With Balloon Catheter System in the Treatment of Femoropopliteal Occlusive Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03380650
• Other study ID #: 2017-092
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2017
• Last updated: December 20, 2017
• Start date: January 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2017
• Source: RenJi Hospital
• Contact: Shuofei Yang, M.D., Ph.D.
• Phone: +86 13764227372
• Email: doctor_yangshuofei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Endovascular Treatment
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• directional atherectomy and locol drug delivery
combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease
• drug-coated balloon dilation
use of drug-coated balloon dilation for the treatment of femoralpopliteal disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late lumen loss rate	the rate of late lumen loss of target vessel	12 months
Primary	patency rate	the rate of patency of target vessel	6 months
Primary	patency rate	the rate of patency of target vessel	12 months
Secondary	MLD	minimal lumen diameter of target vessel at 6 months	12 months
Secondary	clinical outcomes	rate of re-intervention of target vessel	12 months
Secondary	incidence of complications	incidence of treatment induced major complications	12 months
Secondary	re-stenosis rate	the rate of re-stenosis (=50)	12 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