Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-03 @ 11:54 PM
Study NCT ID:
NCT03309969
Status:
UNKNOWN
Last Update Posted:
2017-10-16
First Post:
2017-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062108', 'term': 'May-Thurner Syndrome'}], 'ancestors': [{'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage diameter reduction', 'timeFrame': '1 month', 'description': 'Compare the percentage diameter reduction measured by intravascular ultrasound (IVUS) and venography'}, {'measure': 'Percentage area reduction', 'timeFrame': '1 month', 'description': 'Compare the percentage area reduction measured by IVUS and the calculated percentage area reduction measured by venography'}], 'secondaryOutcomes': [{'measure': 'CEAP score', 'timeFrame': '18 months', 'description': 'Improvement in Clinical, Etiology, Anatomy, Pathophysiology (CEAP) score'}, {'measure': 'Primary patency', 'timeFrame': '18 months', 'description': 'Primary patency can be defined as without additional revascularization of the target lesions, the target vessels are still patent which measured by ultrasound or magentic resonance venography (MRV) and the diameter reduction is \\<50% during follow-up period.'}, {'measure': 'Secondary patency', 'timeFrame': '18 months', 'description': 'Secondary patency can be defined as: with additional revascularization of the target lesions after the first surgery in our department, the target vessels are still patent which measured by ultrasound or magentic resonance venography (MRV) and the diameter reduction is \\<50% during follow-up period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iliac Vein Compression Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare intravascular ultrasound with venography in the diagnosis and treatment of iliac vein compression syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with suspicious iliac vein compression syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 to 90 years\n* Willing to participate in and sign the informed consent\n* Patients with suspicious iliac vein stenosis or compression presented by preoperative magnetic resonance venography (MRV)\n* Patent common femoral vein and/or femoral vein of the study leg\n* Undergoing iliofemoral venography with the intend to treat potential iliac vein compression syndrome\n\nExclusion Criteria:\n\n* Not providing informed consent\n* Venous compression caused by pelvic tumors or fibroid uterus\n* Previous stent implantation or venovenous bypass surgery of the study leg\n* Known metal allergy precluding the possibility of stent implantation\n* Known iodine allergy or severe renal insufficient function which are unsuitable for venography\n* Pregnant or planning to be pregnant recently\n* Acute deep vein thrombosis or tumor thrombus involving the study leg\n* Know history of thrombophilia (e.g. protein C or S deficiency, anti-thrombin III deficiency, etc )\n* Any concurrent disease, for example, heart failure, might make the patients unsuitable for surgery'}, 'identificationModule': {'nctId': 'NCT03309969', 'briefTitle': 'Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Comparison of Intravascular Ultrasound With Venography in the Diagnosis and Treatment of Iliac Vein Compression Syndrome', 'orgStudyIdInfo': {'id': 'B2017-115'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observation group', 'description': 'Subjects with suspicious iliac vein compression syndrome were included in the observation group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenyu Shi, doctor', 'role': 'CONTACT', 'email': 'maxshizhenyu@163.com', 'phone': '+86 18616880807'}, {'name': 'Zhenyu Shi, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yong Ding, Master', 'role': 'SUB_INVESTIGATOR'}], 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhenyu Shi, Doctor', 'role': 'CONTACT', 'email': 'maxshizhenyu@163.com', 'phone': '+86 18616880807'}, {'name': 'Yong Ding, Master', 'role': 'CONTACT', 'email': 'Med.YoungDee@gmail.com', 'phone': '+86 18702171713'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}