A Phase 2/3 interventional study of Bioabsorbable everolimus-eluting stent deployment in Impotence, Arteriogenic, sponsored by National Taiwan University Hospital. Status unknown. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by National Taiwan University Hospital · Phase 2/3, Interventional, and Treatment
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.
683 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.
This study's planned enrollment of 15 is below the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bioabsorbable everolimus-eluting stent deployment
Device: Bioabsorbable everolimus-eluting stent deployment
Bioabsorbable everolimus-eluting stent deployment
CT angiographic binary restenosis
Binary restenosis is defined as \>=50% lumen diameter stenosis
Time frame: 6 months
Diameter measured by invasive angiography
Diameter will be measured by invasive angiography at in-stent, peri-stent, and in-segment sections
Time frame: 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
Time frame: 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
Time frame: 6-9 months
International Index of Erectile Function (IIEF)-5 score
Time frame: 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).
Time frame: 1, 3, 6, and 12 months
No study locations are listed for this record.
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Taiwan University Hospital