Bioabsorbable Everolimus-Eluting Stents for Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction
Primary Purpose
Impotence, Arteriogenic
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bioabsorbable everolimus-eluting stent deployment
Sponsored by
About this trial
This is an interventional treatment trial for Impotence, Arteriogenic focused on measuring bioabsorbable vascular scaffold, erectile dysfunction
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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%;
- serum creatinine levels >2.5 mg/dL;
- bleeding diathesis or known hypercoagulopathy;
- life expectancy of fewer than 12 months;
- known intolerance to contrast agents.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Bioabsorbable everolimus-eluting stent deployment
Outcomes
Primary Outcome Measures
CT angiographic binary restenosis
Binary restenosis is defined as >=50% lumen diameter stenosis
Secondary Outcome Measures
Diameter measured by invasive angiography
Diameter will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Diameter stenosis measured by invasive angiography
Diameter stenosis will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Late loss measured by invasive angiography
Late loss will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
International Index of Erectile Function (IIEF)-5 score
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).
Full Information
NCT ID
NCT02492386
First Posted
June 24, 2015
Last Updated
July 5, 2015
Sponsor
National Taiwan University Hospital
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT02492386
Brief Title
Bioabsorbable Everolimus-Eluting Stents for Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction
Official Title
Safety and Feasibility of Bioabsorbable Everolimus-Eluting Stents for Patients With Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction (PERFECT-ABSORB)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence, Arteriogenic
Keywords
bioabsorbable vascular scaffold, erectile dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Bioabsorbable everolimus-eluting stent deployment
Intervention Type
Device
Intervention Name(s)
Bioabsorbable everolimus-eluting stent deployment
Intervention Description
Bioabsorbable everolimus-eluting stent deployment
Primary Outcome Measure Information:
Title
CT angiographic binary restenosis
Description
Binary restenosis is defined as >=50% lumen diameter stenosis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Diameter measured by invasive angiography
Description
Diameter will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Time Frame
6-9 months
Title
Diameter stenosis measured by invasive angiography
Description
Diameter stenosis will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Time Frame
6-9 months
Title
Late loss measured by invasive angiography
Description
Late loss will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Time Frame
6-9 months
Title
International Index of Erectile Function (IIEF)-5 score
Time Frame
1, 3, 6, and 12 months
Title
Major adverse events
Description
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).
Time Frame
1, 3, 6, and 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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%;
serum creatinine levels >2.5 mg/dL;
bleeding diathesis or known hypercoagulopathy;
life expectancy of fewer than 12 months;
known intolerance to contrast agents.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzung-Dau Wang, MD, PhD
Phone
+886-2-23123456
Ext
65632
Email
tdwang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzung-Dau Wang, MD, PhD
Organizational Affiliation
Natioal Taiwan University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24832642
Citation
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.
Results Reference
background
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Bioabsorbable Everolimus-Eluting Stents for Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction
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