UMIN-CTR Clinical Trial

Basic information
Public title	US-guided puncture and decompression for the management of common femoral artery iatrogenic pseudoaneurysm
Acronym	UP-D trial
Scientific Title	US-guided puncture and decompression for the management of common femoral artery iatrogenic pseudoaneurysm: A randomized controlled trial
Scientific Title:Acronym	UP-D trial
Region	Japan

Condition
Condition	common femoral artery iatrogenic pseudoaneurysm
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of ultrasound-guided puncture and decompression method for the common femoral artery iatrogenic pseudoaneurysm management
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Success rate of the common femoral artery iatrogenic pseudoaneurysm management after 20-30 procedure
Key secondary outcomes	Any adverse event rate due to the procedure of the common femoral artery iatrogenic pseudoaneurysm management

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Common femoral artery iatrogenic pseudoaneurys management with Ultrasound-guided puncture and decompression method: 1) Puncture the pseudoaneurysm with 18-20G indwelling needle with ultrasound-guiding and place the outer of the needle, 2)Aspirate the pseudoaneurysm with 5-10cc syringe with giving a manual compression to the proximal and distal portion of the pseudoaneurysm, 3)Detach the syringe when the aspiration is stopped, with retrieving the outer of the needle after 1-2 minutes compression, 4)keep the manual compression for 20-30 min
Interventions/Control_2	Common femoral artery iatrogenic pseudoaneurys management with ultrasound guided compression: ultrasound is used to identify the chamber and tract of the pseudoaneurysm. The physician places the ultrasound transducer on the pseudoaneurysm tract and compresses it to block blood flow, and keeps the compression for 20-30 minutes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	consecutive cases with common femoral artery iatrogenic pseudoaneurysm
Key exclusion criteria	1. <20-year-old 2. underwent a surgical intervention to the common femoral artery with pseudoaneurysm 3. pseudoaneurysm rupture 4. shock vital
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ueshima
Organization	Kameda Medical Center
Division name	Cardiology
Zip code	296-8602
Address	929 Higashi-cho Kamogawa City
TEL	+81-4-7092-2211
Email	ueshima.daisuke@kameda.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ueshima
Organization	Kameda Medical Center
Division name	Cardiology
Zip code	296-8602
Address	929 Higashi-cho Kamogawa City
TEL	+81-4-7092-2211
Homepage URL
Email	ueshima.daisuke@kameda.jp

Sponsor
Institute	Kameda Medical Center
Institute
Department

Funding Source
Organization	Kameda Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kameda Medical Center Institutional Review Board
Address	929 Higashi-cho Kamogawa City
Tel	+81-4-7092-2211
Email	clinical_research@kameda.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 03 Month 20 Day
Date of IRB	2020 Year 03 Month 27 Day
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2024 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 03 Day
Last modified on	2020 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045643

Research Plan
Registered date	File name
2020/12/18	UP-D trial研究計画書.docx

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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