Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-02-24 @ 3:53 AM
Study NCT ID:
NCT02178761
Status:
UNKNOWN
Last Update Posted:
2014-07-01
First Post:
2014-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging and Interventional Study for Erectile Dysfunction and Lower Urinary Tract Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-30', 'studyFirstSubmitDate': '2014-06-22', 'studyFirstSubmitQcDate': '2014-06-30', 'lastUpdatePostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Any major adverse events', 'timeFrame': '1year'}], 'primaryOutcomes': [{'measure': 'IIEF', 'timeFrame': '1 year', 'description': 'IIEF: Internal index for erectile function'}, {'measure': 'EPS', 'timeFrame': '1 year', 'description': 'EPS: erectile hardness score'}, {'measure': 'IPSS', 'timeFrame': '1 year', 'description': 'IPSS: international prostate symptom score'}], 'secondaryOutcomes': [{'measure': 'CT angiographic binary restenosis', 'timeFrame': '1 year', 'description': 'CT angiographic binary restenosis: ≥50% lumen diameter stenosis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Erectile dysfunction', 'Lower Urinary Tract Symptoms', 'Peripheral Arterial Disease', 'Angioplasty', 'Multidetector Computed Tomography'], 'conditions': ['Erectile Dysfunction', 'Lower Urinary Tract Symptoms', 'Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '24832642', 'type': 'BACKGROUND', 'citation': 'Wang TD, Lee WJ, Yang SC, Lin PC, Tai HC, Hsieh JT, Liu SP, Huang CH, Chen WJ, Chen MF. Safety and six-month durability of angioplasty for isolated penile artery stenoses in patients with erectile dysfunction: a first-in-man study. EuroIntervention. 2014 May;10(1):147-56. doi: 10.4244/EIJV10I1A23.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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\n\nExclusion Criteria:\n\n* the arterial inflow to the penis is entirely from the accessory pudendal arteries rather than the usual internal pudendal artery and common penile artery;\n* the presence of focal diameter stenosis \\>=70% in the common iliac artery, internal iliac artery, or anterior division of internal iliac artery;\n* previous radical prostatectomy, pelvic radiation, or Peyronie\'s disease;\n* untreated hypogonadism (serum total testosterone \\<300 ng/dL within 14 days before enrollment);\n* acute coronary syndrome, stroke, or life-threatening arrhythmia within 3 months before enrollment;\n* poorly controlled diabetes mellitus with glycosylated hemoglobin levels \\>9%;\n* serum creatinine levels \\>2.5 mg/dL;\n* bleeding diathesis or known hypercoagulopathy;\n* life expectancy of fewer than 12 months;\n* known intolerance to contrast agents'}, 'identificationModule': {'nctId': 'NCT02178761', 'acronym': 'PERFECT', 'briefTitle': 'Imaging and Interventional Study for Erectile Dysfunction and Lower Urinary Tract Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comprehensive Imaging and Interventional Therapy Studies for Arteriogenic Erectile Dysfunction and Lower Urinary Tract Symptoms: A Multi-modality, Multi-Specialty Collaborative Study (PERFECT Program)', 'orgStudyIdInfo': {'id': '201402003RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Angioplasty alone', 'description': 'plain old balloon angioplasty alone', 'interventionNames': ['Device: Apex™ PTCA Dilatation Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stenting', 'description': 'Balloon angioplasty plus stenting', 'interventionNames': ['Device: Stent System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'drug-eluting balloon', 'description': 'Balloon angioplasty with drug-eluting balloon', 'interventionNames': ['Device: drug-eluting balloon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'biodegradable vascular scaffold stent', 'description': 'Stenting with biodegradable vascular scaffold stent', 'interventionNames': ['Device: biodegradable vascular scaffold stent']}], 'interventions': [{'name': 'drug-eluting balloon', 'type': 'DEVICE', 'otherNames': ['SeQuent® Please'], 'description': 'angioplasty completed with drug-eluting balloons', 'armGroupLabels': ['drug-eluting balloon']}, {'name': 'biodegradable vascular scaffold stent', 'type': 'DEVICE', 'otherNames': ['Absorb Bioresorbable Vascular Scaffold System'], 'description': 'Stenting with biodegradable vascular scaffold stents', 'armGroupLabels': ['biodegradable vascular scaffold stent']}, {'name': 'Apex™ PTCA Dilatation Catheter', 'type': 'DEVICE', 'otherNames': ['TREK & MINI TREK Coronary Dilatation Catheter', 'Sprinter Legend RX'], 'description': 'plain old balloon angioplasty alone', 'armGroupLabels': ['Angioplasty alone']}, {'name': 'Stent System', 'type': 'DEVICE', 'otherNames': ['Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System', 'XIENCE PRIME Everolimus Eluting Coronary Stent System', 'Resolute Integrity Coronary Stent System', 'BioMatrix Flex™', 'Nobori® Drug Eluting Stent', 'MULTI-LINK 8 Coronary Stent System', 'Integrity Coronary Stent System'], 'description': 'stenting with either bare-metal stents or drug-eluting stents', 'armGroupLabels': ['Stenting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10002', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tzung-Dau Wang, MD, PhD', 'role': 'CONTACT', 'email': 'tdwang@ntu.edu.tw', 'phone': '+886-972651070'}, {'name': 'Tzung-Dau Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wen-Jeng Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tzung-Dau Wang, MD, PhD', 'role': 'CONTACT', 'email': 'tdwang@ntu.edu.tw', 'phone': '+886-972651070'}], 'overallOfficials': [{'name': 'Tzung-Dau Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NTUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}