Recruiting NCT07353905
Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravascular Ultrasound (IVUS), Angiographic-guided Intervention.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease, Lower Extremity Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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).
Interventions
- Device Intravascular Ultrasound (IVUS)
pre-and post-procedural IVUS to guide atherectomy, balloon angioplasty based treatments and/or stent placement - Device Angiographic-guided Intervention
Standard angiography-guided intervention without IVUS.
Primary outcome measures
- Primary Patency [Time frame: From enrollment to 6 months]
Secondary outcome measures (7)
- Technical Success [Time frame: Collected from index procedure]
- Procedural Success [Time frame: Collected from Index procedure]
- Clinically driven-TLR (CD-TLR) [Time frame: From enrollment to 12 months]
- Amputation-free Survival [Time frame: From enrollment to 12 months]
- Functional Status Improvement (Vascular Quality of Life Questionnaire (VascuQoL-6)) [Time frame: From enrollment to 12 months]
- Functional Status Improvement (Rutherford Class Improvement) [Time frame: From enrollment to 12 months]
- Cost Effectiveness [Time frame: Evaluated at 12 months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Symptomatic LE PAD - Rutherford Class 2-5
- Angiographic evidence of >50% stenosis
- Undergoing LE peripheral artery intervention
- 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).
Exclusion criteria
- Prior intervention at the target lesion within 6 months
- Target lesion is abdominal aorta or inframalleolar BTK arteries
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Baylor Scott & White The Heart Hospital - Dallas — Dallas
- Baylor Scott & White The Heart Hospital - Fort Worth — Fort Worth
- Baylor Scott & White The Heart Hospital - Mckinney — McKinney
- The Heart Hospital Baylor Plano — Plano
- Baylor Scott & White Medical Center - Temple — Temple
- Baylor Scott & White The Heart Hospital - Waxahachie — Waxahachie
Publications
- PASS 2025 Power Analysis and Sample Size Software (2025). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
- 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 36265940
- 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 37071719
- 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 40792582
- 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 35272779
- 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 37688486
- 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 39674438
- 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 J PMID 39846915
Identifiers
NCT: NCT07353905 · 025-412