Study of DA+LDD in the Treatment of Femoropopliteal Occlusive Disease
Study of Combined Use of Directional Atherectomy and Local Drug Delivery With Balloon Catheter System in the Treatment of Femoropopliteal Occlusive Disease
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedDecember 21, 2017
December 1, 2017
12 months
December 13, 2017
December 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
late lumen loss rate
the rate of late lumen loss of target vessel
12 months
patency rate
the rate of patency of target vessel
6 months
patency rate
the rate of patency of target vessel
12 months
Secondary Outcomes (8)
MLD
12 months
clinical outcomes
12 months
incidence of complications
12 months
re-stenosis rate
12 months
adverse events
12 months
- +3 more secondary outcomes
Study Arms (2)
durg-coated balloon dilation
OTHERThe drug-coated balloon will be used to treat the femoropopliteal occlusion.
directional atherectomy and LDD
OTHERThe directional atherectomy and local drug delivery will be used to treat the femoropopliteal occlusion.
Interventions
combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease
use of drug-coated balloon dilation for the treatment of femoralpopliteal disease
Eligibility Criteria
You may qualify if:
- age of 18-80 years old
- patients of femoropopliteal occlusive disease (Rutherford 2-4)
- length of lesion ≤ 20cm
- have signed the informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lan Zhang, M.D., Ph.D.
RenJi Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- only the doctor know the group the patient goes into
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2017
First Posted
December 21, 2017
Study Start
January 1, 2018
Primary Completion
December 30, 2018
Study Completion
December 30, 2019
Last Updated
December 21, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share