Comprehensive Imaging and Interventional Therapy Studies for Arteriogenic Erectile Dysfunction and Lower Urinary Tract Symptoms: A Multi-modality, Multi-Specialty Collaborative Study (PERFECT Program)
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- IPSS
研究概览
简要总结
Erectile dysfunction is highly prevalent as men grow older. Among the various causes of erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very important role. The investigators have recently developed the first imaging analytical algorithm by using the abdominal/pelvis multidetector computed tomographic (MDCT) angiography to delineate the whole arterial system supplying the penis. To establish a comprehensive, cutting-edge diagnostic and interventional therapeutic program for erectile dysfunction, the investigators therefore design this series of studies by including experts from Urology, Radiology, and Cardiology. This research project (PERFECT program) includes the following 4 sub-studies: 1) differential frequency of obstructive pelvic arterial lesions in coronary artery disease patients with and without erectile dysfunction/lower urinary tract symptoms (LUTS), 2) differential frequency of obstructive pelvic arterial lesions in patients with vascular risk factors and with or without erectile dysfunction/LUTS, 3) safety, feasibility, and efficacy of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: proof-of-concept study; and 4) efficacy and safety of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: a randomized controlled trial.
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
- None
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 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 pelvic arteries with reference vessel diameter >=2.5 mm and <=4.0 mm and a target-lesion length <=40 mm
排除标准
- •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 iliac artery, internal iliac artery, or anterior division of internal iliac 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
研究组 & 干预措施
Angioplasty alone
plain old balloon angioplasty alone
干预措施: Apex™ PTCA Dilatation Catheter (Device)
Stenting
Balloon angioplasty plus stenting
干预措施: Stent System (Device)
drug-eluting balloon
Balloon angioplasty with drug-eluting balloon
干预措施: drug-eluting balloon (Device)
biodegradable vascular scaffold stent
Stenting with biodegradable vascular scaffold stent
干预措施: biodegradable vascular scaffold stent (Device)
结局指标
主要结局
IPSS
时间窗: 1 year
IPSS: international prostate symptom score
IIEF
时间窗: 1 year
IIEF: Internal index for erectile function
EPS
时间窗: 1 year
EPS: erectile hardness score
次要结局
- CT angiographic binary restenosis(1 year)