Trial reportVascular and endovascular surgery2015
Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study).
Trial report in Vascular and endovascular surgery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal (TRUTH Study)
Evaluation of the Safety and Efficacy of the Chocolate Balloon Catheter in Percutaneous Transluminal Angioplasty (PTA) for Peripheral Arterial Disease (PAD): A Prospective, Multicenter, Single-Arm Observational Trial
Who cites it
12 citing papers in PubMed, 53 citations in OpenAlex.
- Debulking Severe Femoropopliteal Calcification: Mechanical Gain, Biological Limits, and Embolic Risk.JACC. Asia · 2026Article
- Article
- Cutting-edge progress of intravascular ultrasound in lower-extremity vascular interventions.Ultrasonography (Seoul, Korea) · 2025Article
- Endovascular Interventions for Peripheral Artery Disease: A Contemporary Review.Current cardiology reports · 2023Review
- Intravascular ultrasound guidance for lower extremity arterial and venous interventions.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022Review
- Calcific Plaque Modification by Acoustic Shockwaves: Intravascular Lithotripsy in Cardiovascular Interventions.Current cardiology reports · 2022Review
- How Much Debulking with Atherectomy is Enough When Treating Infrainguinal Arterial Interventions? The Balance Between Residual Stenosis and Adventitial Injury.Vascular health and risk management · 2022Article
- An update on vessel preparation in lower limb arterial intervention.CVIR endovascular · 2020Article
- Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Observational
- A post-market, multi-vessel evaluation of the imaging of peripheral arteries for diagnostic purposeS comparing optical Coherence tomogrApy and iNtravascular ultrasound imaging (SCAN).BMC medical imaging · 2020Article
- Minimal Medial Injury After Orbital Atherectomy.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2017Article
- Intravascular Lithotripsy for Peripheral Artery Calcification: Mid-term Outcomes From the Randomized Disrupt PAD III Trial.Journal of the Society for Cardiovascular Angiography & InterventionsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe Tissue Removal Assessment with Ultrasound of the SFA and Popliteal (TRUTH) study assessed the performance of the orbital atherectomy system (OAS) to treat femoropopliteal arteries, including determining its effect on plaque removal.
methodsPatients with symptomatic femoropopliteal peripheral arterial disease were treated with the OAS followed by adjunctive balloon angioplasty (BA). Intravascular ultrasound (IVUS) images were collected pre- and post-OAS and post-OAS BA. Patients were followed through 12 months post-procedure.
resultsTwenty-nine lesions were treated with OAS-BA in 25 patients. The mean maximum balloon inflation pressure was 5.2 ± 1.2 atm. Virtual histology IVUS (VH-IVUS) analysis revealed at the maximum calcium ablation site that calcium reduction was responsible for 86% of the lumen area increase. The minimum lumen area increased from 4.0 mm(2) to 9.1 mm(2) (<.0001), and the percentage of area stenosis decreased from 76.9% to 43.0% (<.0001) after OAS-BA. At 12 months, the target lesion revascularization rate was 8.2%, and ankle-brachial index and Rutherford classification improved significantly from baseline through follow-up.
conclusionThe VH-IVUS analysis reveals that OAS modifies the calcified component of the plaque burden. It is hypothesized that calcium modification by OAS changes the lesion compliance, allowing for low pressure adjunctive BA. The clinical outcomes were favorable through 12-month follow-up.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.