Impotence, ArteriogenicPhase 2/3NCT02492386
Bioabsorbable Everolimus-Eluting Stents for Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction
A Phase 2/3 study testing Bioabsorbable everolimus-eluting stent deployment in people with Impotence, Arteriogenic, run by National Taiwan University Hospital.
Trial summary
In this prospective, unblinded, single-arm, single-center study, investigators would like to assess the feasibility and safety of the bioabsorbable everolimus-eluting stents in patients with erectile dysfunction and concomitant internal pudendal artery stenoses. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Impotence, Arteriogenic
- What is being tested?
- Bioabsorbable everolimus-eluting stent deployment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Mar 2017
- Phase
- Phase 2/3
- 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 internal pudendal arteries with reference vessel diameter ≥2.5 mm and ≤4.0 mm and a target-lesion length ≤30 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 penile artery, internal iliac artery, or anterior division of inferior gluteal 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
No sites are listed yet.
About this study
Official title: Safety and Feasibility of Bioabsorbable Everolimus-Eluting Stents for Patients With Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction (PERFECT-ABSORB)
In this prospective, unblinded, single-arm, single-center study, investigators would like to assess the feasibility and safety of the bioabsorbable everolimus-eluting stents in patients with erectile dysfunction and concomitant internal pudendal artery stenoses. A total of 15 bioabsorbable vascular scaffolds (BVSs) are planned to be assessed and will be deployed in the internal pudendal artery, with a 1:1 ratio of both proximal and distal segments.
Read the detailed description
Background: Obstructive pelvic arterial lesions were present in approximately 70-80% of patients aged >50 years and having erectile dysfunction. Previous studies have shown that most arterial stenoses were present in the internal pudendal and common penile artery segments. Investigators have also demonstrated that angioplasty for both internal pudendal and penile arteries is safe and can achieve clinically significant improvement in erectile function in ~60% of patients with erectile dysfunction. Nevertheless, in the ZEN study and investigators' preliminary observation, the 6-month angiographic binary restenosis rate for drug-eluting stents (DES) in internal pudendal artery approached 30-50%. The internal pudendal artery requires integral vasomotor function to provide sufficient blood supply during erection, whereas metallic stents impair vasomotor function. A fully bioabsorbable drug-eluting stent that scaffolds the vessel wall when needed and then disappear once the acute recoil and constrictive remodeling processes have subsided is therefore particularly advantageous for the internal pudendal artery. Investigators herein would like to assess the feasibility and safety of the bioabsorbable everolimus-eluting stents in patients with erectile dysfunction and concomitant internal pudendal artery stenoses.
Methods: This prospective, unblinded, single-arm, single-center study is a feasibility trial designed to provide preliminary observations and generate hypotheses for future studies. A total of 15 BVSs are planned to be assessed and will be deployed in the internal pudendal artery, with a 1:1 ratio of both proximal and distal segments. All subjects will undergo pelvic CT angiography at baseline and 6 months after intervention. Invasive selective pudendal angiography will be performed 6-9 months after intervention as well. Intravascular ultrasound and/or optical coherence tomography (OCT) imaging will be obtained during invasive angiography. The primary feasibility endpoint is CT angiographic binary restenosis (≥50% lumen diameter stenosis) at 6 months.
- Conditions
- Impotence, Arteriogenic
- Being tested
- Bioabsorbable everolimus-eluting stent deployment
- Keywords
- bioabsorbable vascular scaffold, erectile dysfunction
- Medical subject headings
- Impotence, Vasculogenic, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioabsorbable everolimus-eluting stent deploymentDevice
Bioabsorbable everolimus-eluting stent deployment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Bioabsorbable everolimus-eluting stent deployment Receives: Device: Bioabsorbable everolimus-eluting stent deployment |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT angiographic binary restenosis
Binary restenosis is defined as >=50% lumen diameter stenosis
Measured: 6 months
Secondary outcomes (5)
Diameter measured by invasive angiography
Diameter will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Measured: 6-9 months
Diameter stenosis measured by invasive angiography
Diameter stenosis will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Measured: 6-9 months
Late loss measured by invasive angiography
Late loss will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Measured: 6-9 months
International Index of Erectile Function (IIEF)-5 score
Measured: 1, 3, 6, and 12 months
Major adverse events
Major adverse events are defined as procedure-related death, occurrence of perineal hematoma, gangrene or necrosis (glans penis, penile shaft, scrotal, or anal), or the need for subsequent perineal, penile, or anal surgery (including target-lesion or vessel revascularization or arterial embolization procedures).
Measured: 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2016 (estimated)
- Study completionMar 2017 (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 Impotence, ArteriogenicStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Tzung-Dau Wang, MD, PhD, Principal investigator, Natioal Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492386
- Sponsor's protocol ID
- 201501059DIPB
- Status last verified
- Jul 2015
- First submitted
- 24 Jun 2015
- Last updated
- 8 Jul 2015
- 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 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Bioabsorbable Everolimus-Eluting Stents for Patients With Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction (PERFECT-ABSORB)
- ClinicalTrials.gov ID
- NCT02492386
- Acronym / sponsor ID
- 201501059DIPB
- Conditions
- Impotence, Arteriogenic
- Keywords
- bioabsorbable vascular scaffold, erectile dysfunction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 8 Jul 2015 (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.
In this prospective, unblinded, single-arm, single-center study, investigators would like to assess the feasibility and safety of the bioabsorbable everolimus-eluting stents in patients with erectile dysfunction and concomitant internal pudendal artery stenoses. A total of 15 bioabsorbable vascular scaffolds (BVSs) are planned to be assessed and will be deployed in the internal pudendal artery, with a 1:1 ratio of both proximal and distal segments.
Detailed description
Background: Obstructive pelvic arterial lesions were present in approximately 70-80% of patients aged >50 years and having erectile dysfunction. Previous studies have shown that most arterial stenoses were present in the internal pudendal and common penile artery segments. Investigators have also demonstrated that angioplasty for both internal pudendal and penile arteries is safe and can achieve clinically significant improvement in erectile function in ~60% of patients with erectile dysfunction. Nevertheless, in the ZEN study and investigators' preliminary observation, the 6-month angiographic binary restenosis rate for drug-eluting stents (DES) in internal pudendal artery approached 30-50%. The internal pudendal artery requires integral vasomotor function to provide sufficient blood supply during erection, whereas metallic stents impair vasomotor function. A fully bioabsorbable drug-eluting stent that scaffolds the vessel wall when needed and then disappear once the acute recoil and constrictive remodeling processes have subsided is therefore particularly advantageous for the internal pudendal artery. Investigators herein would like to assess the feasibility and safety of the bioabsorbable everolimus-eluting stents in patients with erectile dysfunction and concomitant internal pudendal artery stenoses.
Methods: This prospective, unblinded, single-arm, single-center study is a feasibility trial designed to provide preliminary observations and generate hypotheses for future studies. A total of 15 BVSs are planned to be assessed and will be deployed in the internal pudendal artery, with a 1:1 ratio of both proximal and distal segments. All subjects will undergo pelvic CT angiography at baseline and 6 months after intervention. Invasive selective pudendal angiography will be performed 6-9 months after intervention as well. Intravascular ultrasound and/or optical coherence tomography (OCT) imaging will be obtained during invasive angiography. The primary feasibility endpoint is CT angiographic binary restenosis (≥50% lumen diameter stenosis) at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Bioabsorbable everolimus-eluting stent deploymentBioabsorbable everolimus-eluting stent deployment |
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 internal pudendal arteries with reference vessel diameter ≥2.5 mm and ≤4.0 mm and a target-lesion length ≤30 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 penile artery, internal iliac artery, or anterior division of inferior gluteal 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 |
|---|---|---|
| Bioabsorbable everolimus-eluting stent deploymentBioabsorbable everolimus-eluting stent deployment | Device | Treatment |
Primary outcome
CT angiographic binary restenosis
Time frame: 6 months
Binary restenosis is defined as >=50% lumen diameter stenosis
5 secondary outcomes
Diameter measured by invasive angiography
Time frame: 6-9 months
Diameter stenosis measured by invasive angiography
Time frame: 6-9 months
Late loss measured by invasive angiography
Time frame: 6-9 months
International Index of Erectile Function (IIEF)-5 score
Time frame: 1, 3, 6, and 12 months
Major adverse events
Time frame: 1, 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- 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.
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
Natioal Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bioabsorbable everolimus-eluting stent deployment in people with Impotence, Arteriogenic, run by National Taiwan University Hospital.
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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (+886-2-23123456 ext. 65632, tdwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT angiographic binary restenosis (time frame: 6 months). 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 NCT02492386, 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 8 Jul 2015.