Erectile DysfunctionPERFECTNCT02178761
Imaging and Interventional Study for Erectile Dysfunction and Lower Urinary Tract Symptoms
A study testing drug-eluting balloon, biodegradable vascular scaffold stent and Apex™ PTCA Dilatation Catheter in people with Erectile Dysfunction and Lower Urinary Tract Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Erectile dysfunction is highly prevalent as men grow older. Among the various causes of erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very important role. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Erectile Dysfunction, Lower Urinary Tract Symptoms, Peripheral Arterial Disease
- What is being tested?
- drug-eluting balloon, biodegradable vascular scaffold stent and Apex™ PTCA Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men 20 years of age or older with "consistent" erectile dysfunction defined as both IIEF-5 scores, taken at least 4 weeks apart, are in the range of 5 to 21 points and with a difference of <=2 points
- the anatomical inclusion criteria, based on pelvic CT angiography, are unilateral luminal diameter stenosis >=70% or bilateral diameter stenoses >=50% in the pelvic arteries with reference vessel diameter >=2.5 mm and <=4.0 mm and a target-lesion length <=40 mm
Who cannot join
- the arterial inflow to the penis is entirely from the accessory pudendal arteries rather than the usual internal pudendal artery and common penile artery;
- the presence of focal diameter stenosis >=70% in the common iliac artery, internal iliac artery, or anterior division of internal iliac artery;
- previous radical prostatectomy, pelvic radiation, or Peyronie's disease;
- untreated hypogonadism (serum total testosterone <300 ng/dL within 14 days before enrollment);
- acute coronary syndrome, stroke, or life-threatening arrhythmia within 3 months before enrollment;
- poorly controlled diabetes mellitus with glycosylated hemoglobin levels >9%;
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- serum creatinine levels >2.5 mg/dL;
- bleeding diathesis or known hypercoagulopathy;
- life expectancy of fewer than 12 months;
- known intolerance to contrast agents
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Tzung-Dau Wang, MD, PhD, +886-972651070, tdwang@ntu.edu.tw
Tzung-Dau Wang, MD, PhD
About this study
Official title: Comprehensive Imaging and Interventional Therapy Studies for Arteriogenic Erectile Dysfunction and Lower Urinary Tract Symptoms: A Multi-modality, Multi-Specialty Collaborative Study (PERFECT Program)
Erectile dysfunction is highly prevalent as men grow older. Among the various causes of erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very important role. The investigators have recently developed the first imaging analytical algorithm by using the abdominal/pelvis multidetector computed tomographic (MDCT) angiography to delineate the whole arterial system supplying the penis. To establish a comprehensive, cutting-edge diagnostic and interventional therapeutic program for erectile dysfunction, the investigators therefore design this series of studies by including experts from Urology, Radiology, and Cardiology. This research project (PERFECT program) includes the following 4 sub-studies: 1) differential frequency of obstructive pelvic arterial lesions in coronary artery disease patients with and without erectile dysfunction/lower urinary tract symptoms (LUTS), 2) differential frequency of obstructive pelvic arterial lesions in patients with vascular risk factors and with or without erectile dysfunction/LUTS, 3) safety, feasibility, and efficacy of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: proof-of-concept study; and 4) efficacy and safety of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: a randomized controlled trial.
- Being tested
- drug-eluting balloon, biodegradable vascular scaffold stent, Apex™ PTCA Dilatation Catheter, Stent System
- Keywords
- Erectile dysfunction, Lower Urinary Tract Symptoms, Peripheral Arterial Disease, Angioplasty, Multidetector Computed Tomography
- Medical subject headings
- Erectile Dysfunction, Lower Urinary Tract Symptoms, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-eluting balloonDevice
Also called SeQuent® Please
angioplasty completed with drug-eluting balloons
biodegradable vascular scaffold stentDevice
Also called Absorb Bioresorbable Vascular Scaffold System
Stenting with biodegradable vascular scaffold stents
Apex™ PTCA Dilatation CatheterDevice
Also called TREK & MINI TREK Coronary Dilatation Catheter, Sprinter Legend RX
plain old balloon angioplasty alone
Stent SystemDevice
Also called Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, Resolute Integrity Coronary Stent System, BioMatrix Flex™
stenting with either bare-metal stents or drug-eluting stents
| Study group | Role | What they receive |
|---|---|---|
| Angioplasty alone | Active comparator | plain old balloon angioplasty alone Receives: Device: Apex™ PTCA Dilatation Catheter |
| Stenting | Active comparator | Balloon angioplasty plus stenting Receives: Device: Stent System |
| drug-eluting balloon | Active comparator | Balloon angioplasty with drug-eluting balloon Receives: Device: drug-eluting balloon |
| biodegradable vascular scaffold stent | Active comparator | Stenting with biodegradable vascular scaffold stent Receives: Device: biodegradable vascular scaffold stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF
IIEF: Internal index for erectile function
Measured: 1 year
EPS
EPS: erectile hardness score
Measured: 1 year
IPSS
IPSS: international prostate symptom score
Measured: 1 year
Secondary outcomes (1)
CT angiographic binary restenosis
CT angiographic binary restenosis: ≥50% lumen diameter stenosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startOct 2012
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzung-Dau Wang, MD, PhD, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178761
- Sponsor's protocol ID
- 201402003RINA
- Acronym
- PERFECT
- Status last verified
- Jun 2014
- First submitted
- 22 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang TD, Lee WJ, Yang SC, Lin PC, Tai HC, Hsieh JT, Liu SP, Huang CH, Chen WJ, Chen MF. Safety and six-month durability of angioplasty for isolated penile artery stenoses in patients with erectile dysfunction: a first-in-man study. EuroIntervention. 2014 May;10(1):147-56. doi: 10.4244/EIJV10I1A23.
PubMed 24832642
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Imaging and Interventional Therapy Studies for Arteriogenic Erectile Dysfunction and Lower Urinary Tract Symptoms: A Multi-modality, Multi-Specialty Collaborative Study (PERFECT Program)
- ClinicalTrials.gov ID
- NCT02178761
- Acronym / sponsor ID
- PERFECT / 201402003RINA
- Keywords
- Erectile dysfunction, Lower Urinary Tract Symptoms, Peripheral Arterial Disease, Angioplasty, Multidetector Computed Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Erectile dysfunction is highly prevalent as men grow older. Among the various causes of erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very important role. The investigators have recently developed the first imaging analytical algorithm by using the abdominal/pelvis multidetector computed tomographic (MDCT) angiography to delineate the whole arterial system supplying the penis. To establish a comprehensive, cutting-edge diagnostic and interventional therapeutic program for erectile dysfunction, the investigators therefore design this series of studies by including experts from Urology, Radiology, and Cardiology. This research project (PERFECT program) includes the following 4 sub-studies: 1) differential frequency of obstructive pelvic arterial lesions in coronary artery disease patients with and without erectile dysfunction/lower urinary tract symptoms (LUTS), 2) differential frequency of obstructive pelvic arterial lesions in patients with vascular risk factors and with or without erectile dysfunction/LUTS, 3) safety, feasibility, and efficacy of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: proof-of-concept study; and 4) efficacy and safety of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Angioplasty alone | Active comparator | Device: Apex™ PTCA Dilatation Catheterplain old balloon angioplasty alone |
| Stenting | Active comparator | Device: Stent SystemBalloon angioplasty plus stenting |
| drug-eluting balloon | Active comparator | Device: drug-eluting balloonBalloon angioplasty with drug-eluting balloon |
| biodegradable vascular scaffold stent | Active comparator | Device: biodegradable vascular scaffold stentStenting with biodegradable vascular scaffold stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- men 20 years of age or older with "consistent" erectile dysfunction defined as both IIEF-5 scores, taken at least 4 weeks apart, are in the range of 5 to 21 points and with a difference of <=2 points
- the anatomical inclusion criteria, based on pelvic CT angiography, are unilateral luminal diameter stenosis >=70% or bilateral diameter stenoses >=50% in the pelvic arteries with reference vessel diameter >=2.5 mm and <=4.0 mm and a target-lesion length <=40 mm
Key exclusion criteria (10 listed)
- the arterial inflow to the penis is entirely from the accessory pudendal arteries rather than the usual internal pudendal artery and common penile artery;
- the presence of focal diameter stenosis >=70% in the common iliac artery, internal iliac artery, or anterior division of internal iliac artery;
- previous radical prostatectomy, pelvic radiation, or Peyronie's disease;
- untreated hypogonadism (serum total testosterone <300 ng/dL within 14 days before enrollment);
- acute coronary syndrome, stroke, or life-threatening arrhythmia within 3 months before enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug-eluting balloonAlso: SeQuent® Pleaseangioplasty completed with drug-eluting balloons | Device | drug-eluting balloon |
| biodegradable vascular scaffold stentAlso: Absorb Bioresorbable Vascular Scaffold SystemStenting with biodegradable vascular scaffold stents | Device | biodegradable vascular scaffold stent |
| Apex™ PTCA Dilatation CatheterAlso: TREK & MINI TREK Coronary Dilatation Catheter, Sprinter Legend RXplain old balloon angioplasty alone | Device | Angioplasty alone |
| Stent SystemAlso: Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, Resolute Integrity Coronary Stent System, BioMatrix Flex™stenting with either bare-metal stents or drug-eluting stents | Device | Stenting |
Primary outcome
IIEF
Time frame: 1 year
IIEF: Internal index for erectile function
EPS
Time frame: 1 year
EPS: erectile hardness score
IPSS
Time frame: 1 year
IPSS: international prostate symptom score
1 secondary outcome
CT angiographic binary restenosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Background: PubMed 24832642Wang TD, Lee WJ, Yang SC, Lin PC, Tai HC, Hsieh JT, Liu SP, Huang CH, Chen WJ, Chen MF. Safety and six-month durability of angioplasty for isolated penile artery stenoses in patients with erectile dysfunction: a first-in-man study. EuroIntervention. 2014 May;10(1):147-56. doi: 10.4244/EIJV10I1A23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzung-Dau Wang, MD, PhD principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug-eluting balloon, biodegradable vascular scaffold stent and Apex™ PTCA Dilatation Catheter in people with Erectile Dysfunction and Lower Urinary Tract Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzung-Dau Wang, MD, PhD (+886-972651070, tdwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.