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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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 coherenc
Sponsor: National Taiwan University Hospital

Current Primary Outcome: CT angiographic binary restenosis [ Time Frame: 6 months ]

Binary restenosis is defined as >=50% lumen diameter stenosis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Diameter measured by invasive angiography [ Time Frame: 6-9 months ]
    Diameter will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
  • Diameter stenosis measured by invasive angiography [ Time Frame: 6-9 months ]
    Diameter stenosis will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
  • Late loss measured by invasive angiography [ Time Frame: 6-9 months ]
    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 [ Time Frame: 1, 3, 6, and 12 months ]
  • Major adverse events [ Time Frame: 1, 3, 6, and 12 months ]
    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).


Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: June 24, 2015
Date Started: July 2015
Date Completion: March 2017
Last Updated: July 5, 2015
Last Verified: July 2015