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