Sirolimus Eluting Balloon Utilization for Treatment of Vasculogenic Erectile Dysfunction - The SUASION Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of Delta International Index of Erectile Function IEF-5 score between basal and 8 months FU (>5)
研究概览
简要总结
Brief Summary:
Background and pathophysiology: Erectile dysfunction (ED) is defined as the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse.
ED is not in itself a "serious" disease, but its impact on quality of life is extremely important, affecting the family and interpersonal relationships.
Male erection is a complex mechanism that involves neuro-vascular tissue responses with several phases including arterial dilatation, smooth muscle cells relaxation and ultimately veno-occlusive activation.
Vasculogenic erectile dysfunction can be divided in arteriogenic (when there is insufficiency of arterial component of erection due to atherosclerotic plaque encroachment of the penile arteries) or venogenic (where there is insufficiency of the venous component of erection for venous endoleak) Standard treatment Erectile dysfunction is commonly treated by oral phosphodiesterase-5-inhibitor (PDE5i) administration. However, up to 50% of men have a suboptimal response to PDE5-i therapy with the need of additional therapies. New treatment Only recently several studies have been published on percutaneous treatment of ED using plain old balloon angioplasty (POBA), Drug eluting balloons (both paclitaxel and sirolimus, PEB and SES) and drug eluting stents (DES).
Aim of the study: Evaluation of the safety and feasibility of sirolimus drug eluting balloon treatment in focal atherosclerotic lesions of the internal pudendal arteries among men with erectile dysfunction (ED) and a no response to phosphodiesterase-5 inhibitors.
详细描述
Erectile dysfunction (ED) is defined as the recurrent inability to achieve and maintain an erection satisfactory for sexual intercourse ED is not in itself a "serious" disease, but its impact on quality of life is extremely important, affecting the family and interpersonal relationships. Depression, shame, decreased self-esteem and relationship problems are commonly reported symptoms and experiences to people suffering from ED.
Therefore, successful treatment of ED has a strong impact on quality of life. More than 150 million men worldwide have ED, and 52% of men in the United States 40 to 70 years of age report some degree of ED.
The male erection is a complex mechanism that involves neuro-vascular-tissue responses. In particular, the erection mechanism includes a phase of arterial dilation, the relaxation of the musculature of the trabecular smooth muscle cells at the level of the cavernous bodies and, ultimately, the activation of a veno-occlusive at the level of the same mechanism.
Restoring adequate arterial inflow in patients with penile arterial insufficiency can improve erectile function. Surgical re-vascularization has been used successfully in younger men after blunt perineal trauma or pelvic fracture. Older subjects can have obstructive atherosclerotic disease identified by angiography in the iliac, internal pudendal, and cavernosal arteries. Although endovascular revascularization with balloon angioplasty has resulted in at least short-term improvement of erectile function, there have been no prior reports on the feasibility of Sirolimus eluting balloon treatment for ED.
ED counts various causes including psychological factors, neurological hormonal, iatrogenic and to particular lifestyle. A careful collection of the clinical history is essential to identify risk factors for ED: present diseases, drug therapies, previous surgery, smoking and use of drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Ejection Fraction below 40%
- •Hemodynamic instability (systolic blood pressure <100 mm Hg; heart rate <40 bpm or >100 bpm; complex ventricular arrhythmias; AtrioVentricular (AV) block) requiring balloon counterpulsation or inotropic support.
- •Patient was never treated with PDE5i
- •Patient has not performed a basal and dynamic pelvic Doppler
- •Patient has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
- •Patient has a white blood cell (WBC) count <3,000 cells/mm3
- •Patient is on dialysis or has known renal insufficiency (serum creatinine > 2 mg/dl, or Glomerular Filtration Rate (GFR) <40)
- •Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
- •Patient has a known allergy to Sirolimus or protocol required concomitant medications (clopidogrel, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
- •Patient has an active peptic ulcer or active gastrointestinal (GI) bleeding
- •Patient has a history of coagulopathy
- •Patient has other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
- •Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
- •Angiographic exclusion criteria
- •Vessel size < 1.5 mm by visual estimation.
- •Lesion length > 80 mm by visual estimation.
- •Restenosis from previous intervention
- •Thrombus, or possible thrombus, present in the target vessel
- •Previous implantation of a bare/DES in the target vessel
结局指标
主要结局
Evaluation of Delta International Index of Erectile Function IEF-5 score between basal and 8 months FU (>5)
时间窗: 1-8 months
The score 22-25 means normal function The score 17-21 means very light erectile disfunction The score 12-16 means light to moderate erectile disfunction The score 8-11 means moderate erectile disfunction The score 5-7 means severe erectile disfunction Delta PSV (\>8) at the Dynamic Doppler evaluation between basal and 8 mos follow-up
次要结局
- Number of participants Reporting Any Medically Attended Adverse Events (MAEs)(1-24 months)
- The rate of Binary Restenosis(1, 6, 12, 24 months)
- Angiographic in-stent late loss measure(1, 6, 12, 24 months)
研究者
Giuseppe Sangiorgi
Professor
Clinica San Gaudenzio