Clinical Of Chocolate Balloon Dilatation Versus Plain Balloon Dilatation to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
1 other identifier
interventional
144
1 country
1
Brief Summary
This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between chocolate balloon and plain balloon dilatation in treatment of infrapopliteal artery lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
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
August 30, 2021
CompletedFirst Submitted
Initial submission to the registry
December 2, 2021
CompletedFirst Posted
Study publicly available on registry
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 12, 2022
October 1, 2022
1.1 years
December 2, 2021
October 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
12-month Primary Patency Rate
systolic velocity ratio \>2.4 as measured by Duplex ultrasound.
12 months
Secondary Outcomes (4)
Technical success rate
1 day
freedom from clinically-driven TLR rate
12 months
Major Adverse Events at 12-month Post Procedure
12 months
12-month Limb Salvage Rate
12 months
Study Arms (2)
Intervention: Chocolate balloon
EXPERIMENTALChocolate balloon group
Intervention: plain balloon
EXPERIMENTALplain balloon group
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gu Yong Quan
Beijing, Beijing Municipality, 100053, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2021
First Posted
December 15, 2021
Study Start
August 30, 2021
Primary Completion
October 1, 2022
Study Completion
December 1, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10