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

Impotence, Arteriogenic Clinical Trial

Official title:

Safety and Feasibility of Bioabsorbable Everolimus-Eluting Stents for Patients With Internal Pudendal Artery-Related Arteriogenic Erectile Dysfunction (PERFECT-ABSORB)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02492386
• Other study ID #: 201501059DIPB
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: June 24, 2015
• Last updated: July 5, 2015
• Start date: July 2015
• Est. completion date: March 2017

Study information

• Verified date: July 2015
• Source: National Taiwan University Hospital
• Contact: Tzung-Dau Wang, MD, PhD
• Phone: +886-2-23123456
• Email: tdwang[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Impotence, Arteriogenic
• Impotence, Vasculogenic

Intervention

Device:
• Bioabsorbable everolimus-eluting stent deployment
Bioabsorbable everolimus-eluting stent deployment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Abbott

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT angiographic binary restenosis	Binary restenosis is defined as >=50% lumen diameter stenosis	6 months	No
Secondary	Diameter measured by invasive angiography	Diameter will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections	6-9 months	No
Secondary	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	No
Secondary	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	No
Secondary	International Index of Erectile Function (IIEF)-5 score		1, 3, 6, and 12 months	No
Secondary	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	Yes