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

• Sponsor: RenJi Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03380650
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 23.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease; Endovascular Treatment	Device: directional atherectomy and locol drug delivery; Device: drug-coated balloon dilation	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: only the doctor know the group the patient goes into
• Primary Purpose: Treatment
• Official Title: Study of Combined Use of Directional Atherectomy and Local Drug Delivery With Balloon Catheter System in the Treatment of Femoropopliteal Occlusive Disease
• Anticipated Study Start Date: Jan 1, 2018
• Anticipated Primary Completion Date: Dec 30, 2018
• Anticipated Study Completion Date: Dec 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: durg-coated balloon dilation The drug-coated balloon will be used to treat the femoropopliteal occlusion.	Device: drug-coated balloon dilation; use of drug-coated balloon dilation for the treatment of femoralpopliteal disease
Other: directional atherectomy and LDD The directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion.	Device: directional atherectomy and locol drug delivery; combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease

Outcome Measures

Primary Outcome Measures

1. late lumen loss rate [12 months]

   the rate of late lumen loss of target vessel

2. patency rate [6 months]

   the rate of patency of target vessel

3. patency rate [12 months]

   the rate of patency of target vessel

Secondary Outcome Measures

1. MLD [12 months]

   minimal lumen diameter of target vessel at 6 months

2. clinical outcomes [12 months]

   rate of re-intervention of target vessel

3. incidence of complications [12 months]

   incidence of treatment induced major complications

4. re-stenosis rate [12 months]

   the rate of re-stenosis (≥50)

5. adverse events [12 months]

   incidence of treatment related adverse events

6. Rutherford level [12 months]

   change of Rutherford level

7. ABI [12 months]

   change of ankle brachial index

8. main amputation [12 months]

   rate of main amputation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• RenJi Hospital

Investigators

• Principal Investigator: Lan Zhang, M.D., Ph.D., RenJi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RenJi Hospital
• ClinicalTrials.gov Identifier: NCT03380650
• Other Study ID Numbers: 2017-092
• First Posted: Dec 21, 2017
• Last Update Posted: Dec 21, 2017
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by RenJi Hospital: femoropopliteal occlusive disease; directional atherectomy; local drug delivery; endovascular treatment
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

No Results Posted as of Dec 21, 2017