LDD in Treatment of Femoropopliteal ISR
Study of Local Drug Delivery in the Treatment of Femoropopliteal In-stent Restenosis
1 other identifier
interventional
40
1 country
1
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.
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
1 active site
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
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedMay 11, 2018
April 1, 2018
1.3 years
April 30, 2018
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
target lesion revascularization
the revascularization rate of target lesion
12 months
Secondary Outcomes (9)
MLD
6 months
restenosis rate
6 months
adverse events
12 months
Rutherford level
12 months
ABI
12 months
- +4 more secondary outcomes
Study Arms (2)
balloon dilation only
EXPERIMENTALThe balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
balloon dilation+local drug delivery
EXPERIMENTALThe balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.
Interventions
The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- only the doctors know the group the patient goes into
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2018
First Posted
May 11, 2018
Study Start
January 1, 2018
Primary Completion
April 30, 2019
Study Completion
October 31, 2019
Last Updated
May 11, 2018
Record last verified: 2018-04