UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008915 |
|---|---|
| Receipt number | R000010456 |
| Scientific Title | Efficacy and feasibility of endovascular therapy with drug-eluting stents for patients with arteriogenic erectile dysfunction |
| Date of disclosure of the study information | 2012/09/18 |
| Last modified on | 2013/09/30 18:09:54 |
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Basic information
Public title
Efficacy and feasibility of endovascular therapy with drug-eluting stents for patients with arteriogenic erectile dysfunction
Acronym
Endovascular therapy for erectile dysfunction
Scientific Title
Efficacy and feasibility of endovascular therapy with drug-eluting stents for patients with arteriogenic erectile dysfunction
Scientific Title:Acronym
Endovascular therapy for erectile dysfunction
Region
| Japan |
Condition
Condition
erectile dysfunction
Classification by specialty
| Cardiology | Urology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of endovascular therapy with drug-eluting stents in patients with arteriogenic erectile dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of endovascular therapy within 6 months. The maximum score in monthly investigation of International Index of Erectile Function 5 (IIEF5, a well-known subjective classification of ED) will be compared with baseline.
Key secondary outcomes
Efficacy of endovascular therapy at 6 months. The IIEF5 score at 6th month will be compared with baseline.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endocvascular therapy including drug-eluting stent implantation to stenosed or occluded pelvic arteries (mainly inferior pudendal arteries).
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1. Patients with moderate or severe ED (IIEF more than / equal 12 at baseline)
2. Patients with stenotic or occluded erectile associated arteries detected by contrast enhanced computed tomography
Key exclusion criteria
1. Patients with known other etiologies of ED
2. Untreated stenotic / occluded lesions in iliac arteries
3. Jailed internal iliac arteries by stents implanted in common / external iliac arteries
4. History of surgical treatment of iliac arteries
5. Patients with controversy for or poor adherence to dual antiplatelet therapy
6. Patients with untreated coronary artery disease
7. Patients with left ventricular dysfuinction (LVEF less than 40%)
8. Patients with severe chronic kidney disease (eg. serum creatinine level more than 2.0mg/dL)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yo Iwata |
Organization
Chiba University Hospital
Division name
Department of Cardiology
Zip code
Address
1-8-1 Inohana Chuo-ku Chiba city Chiba
TEL
0432262340
yoiwata-chiba@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yo Iwata |
Organization
Chiba University Hospital
Division name
Center for Cardiovascular Interventions
Zip code
Address
1-8-1 Inohana Chuoku Chiba
TEL
0432262340
Homepage URL
yoiwata-chiba@umin.org
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2012 | Year | 09 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 14 | Day |
Last modified on
| 2013 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010456
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
