UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevention of Contrast Induced Nephropathy after Endovascular Therapy combined with Carbon Dioxide-digital subtraction angiography in Patients With Ilio-Femoropopliteal artery diseases
Title of the study (Brief title)	CineCD
Region	Japan

Condition
Condition	peripheral artery disease
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the Prevention of Contrast Induced Nephropathy after Endovascular Therapy combined with Carbon Dioxide-digital subtraction angiography(DSA) in Patients With Ilio-Femoropopliteal artery diseasese.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of Contrast Induced Nephropathy
Key secondary outcomes	1)Safety of Endovascular Therapy with Carbon Dioxide-digital subtraction angiography(DSA) 2)Comparison of ABI change after Endovascular Therapy 3)volume of contrast media, injection volume of Carbon Dioxide, Procedure time, Endovascular Therapy related complication 4)comparison of final angiography in Endovascular Therapy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver Other
Interventions/Control_1	Randomized Control arm With 60>eGFR>or=30 mL/min/1.73 m2: contrast media-digital subtraction angiography
Interventions/Control_2	Randomized CO2 usage arm With 60>eGFR>or=30 mL/min/1.73 m2: contrast media combined with Carbon Dioxide digital subtraction angiography
Interventions/Control_3	intervention CO2 usage arm with eGFR<30 mL/min/1.73 m2: contrast media combined with Carbon Dioxide digital subtraction angiography
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	PAD patient recommended endovascular therapy in Patients With Ilio-Femoropopliteal artery diseases and estimated Glomerular Filtration Rate is less than 60ml/min./1.73m2. not exclusion criteria patient. patients with agreement for this study.
Key exclusion criteria	1)Life expectancy 6 months. 2)without regular dialysis 3)under 30years old 4)inappropriate patient determined from study director. 5)patient unavailable of anti platelet agents and anticoagulant. 6)Allergy of contrast agents.
Target sample size	100

Research contact person
Name of lead principal investigator	Michiaki Higasitani
Organization	Sakakibara Heart Institute
Division name	Department of Cardiology
Address	3-16-1 Asahi-cyo Futyu-shi Tokyo
TEL	042-314-3111
Email	mhigashi@shi.heart.or.jp

Public contact
Name of contact person	Clinical Trials Support Office
Organization	Sakakibara Heart Institute
Division name	Clinical Trials Support Office
Address	3-16-1 Asahi-cyo Futyu-shi Tokyo
TEL	042-314-3111
Homepage URL
Email	tikenjim@shi.heart.or.jp

Sponsor
Institute	Sakakibara Heart Institute
Institute
Department

Funding Source
Organization	Japan Research Promotion Society for Cardiovascular Disease
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 07 Day
Anticipated trial start date	2013 Year 10 Month 07 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 08 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014009