Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 9:43 PM
Study NCT ID:
NCT07353905
Status:
RECRUITING
Last Update Posted:
2026-03-19
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018084', 'term': 'Ultrasonography, Interventional'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-03-10', 'size': 614277, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-03-17T13:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized controlled study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Patency', 'timeFrame': 'From enrollment to 6 months', 'description': 'Freedom from restenosis ≥50% or an increase in Duplex Ultrasound peak systolic velocity ≥2.5 times reference proximal segment or target lesion revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Technical Success', 'timeFrame': 'Collected from index procedure', 'description': 'Technical success is defined as less than 30% residual stenosis in the target lesion following the index procedure. Residual stenosis determined by operator visual estimation.'}, {'measure': 'Procedural Success', 'timeFrame': 'Collected from Index procedure', 'description': 'Procedural success is technical success (less than 30 % residual stenosis in the target lesion) without the occurrence of procedural complications during the index procedure. Residual stenosis determined by operator visual estimation.'}, {'measure': 'Clinically driven-TLR (CD-TLR)', 'timeFrame': 'From enrollment to 12 months', 'description': 'Clinically driven-target limb revascularization. Information collected from the medical record.'}, {'measure': 'Amputation-free Survival', 'timeFrame': 'From enrollment to 12 months', 'description': 'Defined as no evidence of amputation. Information is collected from the medical record'}, {'measure': 'Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6))', 'timeFrame': 'From enrollment to 12 months', 'description': 'Vascular Quality of Life Questionnaire (VascuQoL-6) collected at index procedure and 12 months.'}, {'measure': 'Functional Status Improvement (Rutherford Class Improvement)', 'timeFrame': 'From enrollment to 12 months', 'description': 'Rutherford class determined by physician and collected from the medical record.'}, {'measure': 'Cost Effectiveness', 'timeFrame': 'Evaluated at 12 months', 'description': 'This analysis will calculate total cost-effectiveness by comparing costs between the two groups. Total cost will include the initial procedural cost, costs related to complications, and costs of any repeat reinterventions during follow-up.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intravascular Ultrasound', 'Angioplasty', 'Endovascular Treatment'], 'conditions': ['Peripheral Arterial Disease', 'Lower Extremity Arterial Disease']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'PASS 2025 Power Analysis and Sample Size Software (2025). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.'}, {'pmid': '36265940', 'type': 'BACKGROUND', 'citation': 'Divakaran S, Parikh SA, Hawkins BM, Chen S, Song Y, Banerjee S, Rosenfield K, Secemsky EA. Temporal Trends, Practice Variation, and Associated Outcomes With IVUS Use During Peripheral Arterial Intervention. JACC Cardiovasc Interv. 2022 Oct 24;15(20):2080-2090. doi: 10.1016/j.jcin.2022.07.050.'}, {'pmid': '37071719', 'type': 'BACKGROUND', 'citation': 'Rymer JA, Secemsky EA. Use of Intravascular Ultrasound to Optimize Peripheral Vascular Interventions: How Do We Optimize Outcomes and Improve Uptake? Circ Cardiovasc Interv. 2023 Apr;16(4):e013016. doi: 10.1161/CIRCINTERVENTIONS.123.013016. Epub 2023 Apr 18. No abstract available.'}, {'pmid': '40792582', 'type': 'BACKGROUND', 'citation': 'Shin J, Ahn CM, Lee SJ, Lee SH, Lee YJ, Kim BK, Hong MK, Jang Y, Kim TH, Park HW, Jang JY, Lee JH, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS-DCB investigators. Twenty-Four-Month Outcomes of Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease. J Am Heart Assoc. 2025 Aug 19;14(16):e041564. doi: 10.1161/JAHA.125.041564. Epub 2025 Aug 12.'}, {'pmid': '35272779', 'type': 'BACKGROUND', 'citation': 'Allan RB, Puckridge PJ, Spark JI, Delaney CL. The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial. JACC Cardiovasc Interv. 2022 Mar 14;15(5):536-546. doi: 10.1016/j.jcin.2022.01.001.'}, {'pmid': '37688486', 'type': 'BACKGROUND', 'citation': 'Meng W, Guo J, Pan D, Guo L, Gu Y. Intravascular Ultrasound-Guided Versus Angiography-Guided Endovascular Therapy for Femoropopliteal Artery Disease: A Scoping Review. J Endovasc Ther. 2025 Jun;32(3):627-634. doi: 10.1177/15266028231197396. Epub 2023 Sep 9.'}, {'pmid': '39674438', 'type': 'BACKGROUND', 'citation': 'Jang JS, Jin HY, Park YA, Yang TH, Seo JS, Kim DK, Wi JH. Meta-Analysis of Intravascular Ultrasound-Guided Versus Angiography-Guided Endovascular Treatment in Lower Extremity Artery Disease. Am J Cardiol. 2025 Mar 15;239:8-17. doi: 10.1016/j.amjcard.2024.12.012. Epub 2024 Dec 12.'}, {'pmid': '39846915', 'type': 'BACKGROUND', 'citation': 'Lee SJ, Kim TH, Lee JH, Ahn CM, Lee SH, Lee YJ, Kim BK, Hong MK, Jang Y, Park HW, Jang JY, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS-DCB Investigators. Intravascular Ultrasound-Guided vs Angiography-Guided Drug-Coated Balloon Angioplasty in Patients With Complex Femoropopliteal Artery Disease. JACC Cardiovasc Interv. 2025 Mar 10;18(5):558-569. doi: 10.1016/j.jcin.2024.10.052. Epub 2025 Jan 22.'}, {'pmid': '37210800', 'type': 'BACKGROUND', 'citation': 'Soney H, Kakkilaya A, Vazquez DF, Banerjee R, Rosol Z, Tsai S, Banerjee S. Reproducibility of Femoropopliteal Artery Intravascular Ultrasound Imaging in Patients With Peripheral Artery Disease. Am J Cardiol. 2023 Jul 15;199:1-6. doi: 10.1016/j.amjcard.2023.04.026. Epub 2023 May 19.'}]}, 'descriptionModule': {'briefSummary': 'This study will test whether using ultrasound imaging within blood vessels during minimally invasive treatment of leg arteries in patients with peripheral artery disease leads to better clinical outcomes.', 'detailedDescription': 'This is a U.S. prospective multicenter randomized controlled trial to evaluate the clinical outcomes of Intravascular ultrasound (IVUS) guided Lower Extremity (LE) endovascular intervention in patients with symptomatic peripheral artery disease (PAD) (Rutherford class 2-5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Symptomatic LE PAD - Rutherford Class 2-5\n* Angiographic evidence of \\>50% stenosis\n* Undergoing LE peripheral artery intervention\n* Target lesion is iliac, femoropopliteal, profunda or supramalleolar below-the-knee arteries (target lesions extending into the abdominal aorta and inframalleolar BTK may be included).\n\nExclusion Criteria:\n\n* Prior intervention at the target lesion within 6 months\n* Target lesion is abdominal aorta or inframalleolar BTK arteries'}, 'identificationModule': {'nctId': 'NCT07353905', 'acronym': 'INVIGOR', 'briefTitle': 'Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Baylor Research Institute'}, 'officialTitle': 'Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries', 'orgStudyIdInfo': {'id': '025-412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravascular Ultrasound (IVUS)', 'description': 'Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion.', 'interventionNames': ['Device: Intravascular Ultrasound (IVUS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Intravascular Ultrasound (IVUS)', 'description': 'Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion.', 'interventionNames': ['Device: Angiographic-guided Intervention']}], 'interventions': [{'name': 'Intravascular Ultrasound (IVUS)', 'type': 'DEVICE', 'description': 'pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement', 'armGroupLabels': ['Intravascular Ultrasound (IVUS)']}, {'name': 'Angiographic-guided Intervention', 'type': 'DEVICE', 'description': 'Standard angiography-guided intervention without IVUS.', 'armGroupLabels': ['Non-Intravascular Ultrasound (IVUS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Hale', 'role': 'CONTACT', 'email': 'sarah.hale@bswhealth.org', 'phone': '469-814-4845'}, {'name': 'Sarah Weideman', 'role': 'CONTACT', 'email': 'sarah.weideman@bswhealth.org', 'phone': '214-820-2927'}, {'name': 'Subhash Banerjee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zachary Rosol, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Javier Vasquez, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Georges Feghali, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Baylor Scott & White The Heart Hospital - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Theresa Cheyne', 'role': 'CONTACT', 'email': 'Theresa.Cheyne@BSWHealth.org', 'phone': '817-922-2579'}, {'name': 'Mohammad Alqaim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor Scott & White The Heart Hospital - Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '75071', 'city': 'McKinney', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Denise Espinoza', 'role': 'CONTACT', 'email': 'Denise.Espinoza@BSWHealth.org', 'phone': '(469) 814-4783'}, {'name': 'Erisa Stokes, BS', 'role': 'CONTACT', 'email': 'erisa.stokes@bswhealth.org'}, {'name': 'Robert Widmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Arash Shirvani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joseph Liechty, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sanjeev Trehan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Baylor Scott & White The Heart Hospital - Mckinney', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Osniel Gonzalez Ramos, BS', 'role': 'CONTACT', 'email': 'osniel.gonzalezramos@bswhealth.org', 'phone': '469-814-4862'}, {'name': 'Erisa Stokes, BS', 'role': 'CONTACT', 'email': 'erisa.stokes@bswhealth.org', 'phone': '469-814-4819'}, {'name': 'Sameh Sayfo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chadi Dib, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'John Kedora, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mazin Foteh, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Srinivasa Potluri, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dennis Gable, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Margarite Grable', 'role': 'CONTACT', 'email': 'Margarite.Grable@BSWHealth.org', 'phone': '254-724-5861'}, {'name': 'Christian Wintz', 'role': 'CONTACT', 'email': 'christian.wintz@bswhealth.org'}, {'name': 'Timothy Mixon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Clint Malone, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Baylor Scott & White Medical Center - Temple', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '75165', 'city': 'Waxahachie', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Hale', 'role': 'CONTACT', 'email': 'sarah.hale@bswhealth.org', 'phone': '469-814-4845'}, {'name': 'Sarah Weideman', 'role': 'CONTACT', 'email': 'sarah.weideman@bswhealth.org', 'phone': '214-820-2927'}, {'name': 'Christopher Henry, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor Scott & White The Heart Hospital - Waxahachie', 'geoPoint': {'lat': 32.38653, 'lon': -96.84833}}], 'centralContacts': [{'name': 'Sarah Hale', 'role': 'CONTACT', 'email': 'sarah.hale@bswhealth.org', 'phone': '469-814-4845'}, {'name': 'Sarah Weideman', 'role': 'CONTACT', 'email': 'sarah.weideman@bswhealth.org', 'phone': '214-820-2927'}], 'overallOfficials': [{'name': 'Subhash Banerjee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor Scott & White Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "We will need to get Information Security and sponsor approval before sharing our data. Any data shared would be aggregate, de-identified data shared in accordance with Baylor Scott \\& White Research Institute's policies and procedures."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}