UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Angiographic dissection patterns and associated patency outcomes post balloon angioplasty for superficial femoral artery lesions
Title of the study (Brief title)	Dissection Study
Region	Japan

Condition
Condition	Symptomatic peripheral arterial disease with SFA
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the angiographic dissection patterns post balloon angioplasty for superficial temporal artery (SFA) lesions, the clinical outcome associated with each dissection pattern, and predictive factors of severe dissection.
Basic objectives2	Others
Basic objectives -Others	Cross sectional study
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary measure was the angiographic dissection pattern following balloon angioplasty.
Key secondary outcomes	Secondary measures were [1] primary patency and clinically driven target lesion revascularization (TLR) among balloon-alone procedure patients based on dissection patterns, and [2] predictive factors for severe dissection.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Symptoms were classified based on the Rutherford category classifications, and all patients were between class 2 and 6.The main inclusion criteria were single or sequential de novo lesions (>70% diameter reduction or occlusion) in the SFA segment for a reference vessel diameter of 3-7mm
Key exclusion criteria	Cases treated by a direct stent implantation strategy without balloon angioplasty or no angiography after balloon angioplasty was excluded from this study. In-stent restenosis lesion cases were also excluded.
Target sample size	621

Research contact person
Name of lead principal investigator	Masahiko Fujihara
Organization	Kishiwada Tokushukai Hospital
Division name	Cardiology
Address	4-27-1 Kamoricho Kishiwada city Osaka
TEL	072-445-9915
Email	masahiko-fujihara@themis.ocn.ne.jp

Public contact
Name of contact person	Masahiko Fujihara
Organization	Kishiwada Tokushukai Hospital
Division name	Cardiology
Address	4-27-1 Kamoricho Kishiwada city Osaka
TEL	072-445-9915
Homepage URL
Email	masahiko-fujihara@themis.ocn.ne.jp

Sponsor
Institute	Kishiwada Tokushukai Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	坂総合病院　循環器内科　佐々木伸也 東京労災病院　循環器科　宇都宮誠 関西労災病院　循環器内科　南都清範

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 02 Day
Anticipated trial start date	2015 Year 08 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	a retrospective, multicenter, clinical investigation.

Management information
Registered date	2016 Year 08 Month 20 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027295