Feasibility and Safety of Selution SLR™ Sirolimus-eluting Balloon in Patients With Distal Internal Pudendal-penile Artery Disease and Erectile Dysfunction: : PERFECT-SELUTION First-in-man (FIM)
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
According to epidemiological surveys in various countries around the world, the prevalence of erectile dysfunction in men over the age of 40 is about 40%. Previous angiography studies have shown that nearly 70% of erectile dysfunction patients do have pelvic arterial stenosis. Our team leads the world in the use of percutaneous angioplasty combined with drug-eluting stents or paclitaxel-coated balloons to delineate the stenosis of the pelvic pudendal artery and penile artery The successful report of erectile dysfunction shows that the 12-month erectile function improvement rate is nearly 60%, and the vascular restenosis rate is also about 40% to 50%, obviously there is room for improvement. This study aims to observe the clinical efficacy, safety and lower restenosis rate of the newly developed "Selution SLR™ sirolimus drug sustained-release coated balloon" in patients with distal internal pudendal artery and penile artery stenosis complicated with erectile dysfunction . Compared with drug-eluting stents and paclitaxel drug-coated balloons, the Sirolimus drug-coated balloon has two advantages: one is that the clinical performance of sirolimus is much better than that of paclitaxel when used in drug-eluting stents; the other is that there is no indwelling stent in the Therefore, it can reduce the local stimulation of blood vessels and maintain the biological activity of blood vessels. Selution SLR™ sirolimus drug sustained-release coated balloon has obtained European Union approval for marketing, and has also been granted four Breakthrough Device Designation Status by the U.S. Food and Drug Administration (FDA): coronary artery disease, coronary artery disease In-stent restenosis, infra-knee artery disease, and arteriovenous canals.
详细描述
Study Design
- Prospective, randomized, single-blinded, two-arm, single-center, first-in-man, proof-of-concept trial.
- Safety and efficacy measures will be monitored and collected by the study physician/coordinator at hospital discharge, 2 weeks, 1, 3 (12 weeks), 6, and 8 (7-9, study end) months after the index procedure.
- For patients developing binary restenosis at 12 weeks, angioplasty with Selution SLR drug-eluting balloon (in the drug-eluting balloon [DEB] arm) or plain old balloon (POB)(in the POB arm) will be performed thereafter and secondary patency will be evaluated 5 months later, the originally defined 8-month follow-up.
Target Population
- Patient profile: Patients with erectile dysfunction according to International Index of Erectile Function-Erectile Function (IIEF-EF) score and distal internal pudendal and/or penile artery stenotic disease identified by pelvic computed tomography angiography (CTA) and confirmed by invasive angiography.
- Inclusion criteria 2.1 Men ≥20 years of age with erectile dysfunction defined as an IIEF-EF score of ≤25 points; 2.2 The anatomical inclusion criteria, based on pelvic CT angiography, are luminal diameter stenosis of ≥50% in the distal internal pudendal and/or penile arteries with proximal reference vessel diameter of ≥1.5 mm and a target-lesion length of ≤40 mm.
Patients and Sites A total of 54 patients, with at least 54 evaluable lesions, from National Taiwan University Hospital will be enrolled in this trial. 1:2 randomization (18 and 36 in plain old balloon group and Selution group, respectively) will be performed. Pre-specified interim analyses for the primary efficacy outcome measure with an option to prematurely end the study will be conducted while 12, 20, 28, and 36 patients complete evaluation of the primary efficacy measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant will be masked about which treatment strategy will be executed. Randomization will be done after diagnostic invasive pelvic angiography. The intervention procedure between both randomization groups is comparable, thus unmasking is difficult.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ≥20 years of age with erectile dysfunction defined as an IIEF-EF score of ≤25 points;
- •Inadequate response to any dosage of phosphodiesterase 5 inhibitor (PDE5i) for more than 6 months before enrollment (either chronic or on-demanding).
- •Hemodynamic conditions stable (systolic BP > 100 mmHg, heart rate 40-100/min).
- •The anatomical inclusion criteria, based on pelvic CT angiography, are luminal diameter stenosis of ≥50% in the distal internal pudendal and/or penile arteries with proximal reference vessel diameter of ≥1.5 mm and a target-lesion length of ≤40 mm;
排除标准
- •The presence of diameter stenosis of ≥70% in the ipsilateral internal iliac artery, anterior division of internal iliac artery, and/or proximal internal pudendal artery, which could not be successfully treated by angioplasty and stenting;
- •Any non-vascular cause of erectile dysfunction (i.e., pelvic irradiation, pelvic trauma, Peyronie's disease, etc.), which is deemed irreversible by urologist;
- •Untreated hypogonadism (serum total testosterone <2.5 ng/ml) within 28 days before enrollment;
- •Isolated penile veno-occlusive dysfunction (venous leak) by duplex ultrasonography with right or left cavernosal artery end-diastolic velocity >10 cm/s, peak systolic velocity >40 cm/s, and resistance index (RI) <0.75;
- •Acute coronary syndrome, stroke, or life-threatening arrhythmia within 3 months before enrollment;
- •Poorly controlled diabetes mellitus with glycosylated hemoglobin levels >9%;
- •Patient on dialysis or has known renal insufficiency (serum creatinine > 2.5 mg/dl, or estimated Glomerular Filtration Rate <30 ml/min/1.732);
- •Serum creatinine levels >3.0 mg/dl;
- •Bleeding diathesis (like active peptic ulcer, active bleeding, etc.) precluding the use of antiplatelets or anticoagulants or known hypercoagulopathy;
- •Any malignancy or debilitating disease with life expectancy of fewer than 12 months;
- •Known intolerance to contrast agents, aspirin, heparin, all P2Y12 inhibitors, or sirolimus.
- •Severe hepatic insufficiency;
结局指标
主要结局
Primary efficacy endpoint
时间窗: 12 weeks
CT angiographic binary restenosis (≥50% lumen diameter stenosis) at 12 weeks follow-up.
Primary safety endpoint
时间窗: 12 weeks
The rate of major adverse events at 12 weeks after intervention, 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).
次要结局
未报告次要终点