Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular Ultrasound (IVUS) | Active Comparator | Intravascular Ultrasound (IVUS) is used during the treatment of the target lesion. |
|
| Non-Intravascular Ultrasound (IVUS) | Active Comparator | Intravascular Ultrasound (IVUS) is not used in the treatment of the target lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular Ultrasound (IVUS) | Device | pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency | Freedom from restenosis ≥50% or an increase in Duplex Ultrasound peak systolic velocity ≥2.5 times reference proximal segment or target lesion revascularization (TLR). | From enrollment to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | 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. | Collected from index procedure |
| Procedural Success |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Hale | Contact | 469-814-4845 | sarah.hale@bswhealth.org | |
| Sarah Weideman | Contact | 214-820-2927 | sarah.weideman@bswhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Subhash Banerjee, MD | Baylor Scott & White Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor Scott & White The Heart Hospital - Dallas | Recruiting | Dallas | Texas | 75226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | PASS 2025 Power Analysis and Sample Size Software (2025). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass. | ||
| 36265940 | Background | 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. | |
| 37071719 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2026 |
Not provided
Prospective randomized controlled study.
Not provided
Not provided
Single-blind
| Angiographic-guided Intervention | Device | Standard angiography-guided intervention without IVUS. |
|
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.
| Collected from Index procedure |
| Clinically driven-TLR (CD-TLR) | Clinically driven-target limb revascularization. Information collected from the medical record. | From enrollment to 12 months |
| Amputation-free Survival | Defined as no evidence of amputation. Information is collected from the medical record | From enrollment to 12 months |
| Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6)) | Vascular Quality of Life Questionnaire (VascuQoL-6) collected at index procedure and 12 months. | From enrollment to 12 months |
| Functional Status Improvement (Rutherford Class Improvement) | Rutherford class determined by physician and collected from the medical record. | From enrollment to 12 months |
| Cost Effectiveness | 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. | Evaluated at 12 months |
| Baylor Scott & White The Heart Hospital - Fort Worth | Not yet recruiting | Fort Worth | Texas | 76104 | United States |
|
| Baylor Scott & White The Heart Hospital - Mckinney | Recruiting | McKinney | Texas | 75071 | United States |
|
| The Heart Hospital Baylor Plano | Recruiting | Plano | Texas | 75093 | United States |
|
| Baylor Scott & White Medical Center - Temple | Not yet recruiting | Temple | Texas | 76508 | United States |
|
| Baylor Scott & White The Heart Hospital - Waxahachie | Recruiting | Waxahachie | Texas | 75165 | United States |
|
| Background |
| 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. |
| 40792582 | Background | 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. |
| 35272779 | Background | 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. |
| 37688486 | Background | 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. |
| 39674438 | Background | 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. |
| 39846915 | Background | 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. |
| 37210800 | Background | 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. |
| Jul 7, 2026 |
| Prot_SAP_003.pdf |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018084 | Ultrasonography, Interventional |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided