Bioabsorbable Everolimus-Eluting Stents for Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction

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.

Study Overview

• Status: Unknown
• Conditions: Impotence, Arteriogenic
• Intervention / Treatment: Device: Bioabsorbable everolimus-eluting stent deployment

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Bioabsorbable everolimus-eluting stent deployment	Device: Bioabsorbable everolimus-eluting stent deployment; Bioabsorbable everolimus-eluting stent deployment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT angiographic binary restenosis	Binary restenosis is defined as >=50% lumen diameter stenosis	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diameter measured by invasive angiography	Diameter will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections	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	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	6-9 months
International Index of Erectile Function (IIEF)-5 score		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).	1, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Abbott
• Investigators: Principal Investigator: Tzung-Dau Wang, MD, PhD, Natioal Taiwan University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 5, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 8, 2015
• Last Update Submitted That Met QC Criteria: July 5, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: erectile dysfunction; bioabsorbable vascular scaffold
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Impotence, Vasculogenic; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 201501059DIPB