Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2015 Oct;49(7):188-94.
doi: 10.1177/1538574415607361. Epub 2015 Oct 20.

Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study)

Anvar Babaev  1 , Susanna Zavlunova  2 , Michael J Attubato  2 , Brad J Martinsen  3 , Gary S Mintz  4 , Akiko Maehara  4
Affiliations
Clinical Trial

Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study)

Anvar Babaev et al. Vasc Endovascular Surg. 2015 Oct.

Abstract

Objective: The 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.

Methods: Patients 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.

Results: Twenty-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.

Conclusion: The 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.

Trial registration: ClinicalTrials.gov NCT01938391.

Keywords: calcification; intravascular ultrasound; orbital atherectomy; peripheral arterial disease.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A. Babaev has an investigator's agreement with Cardiovascular Systems, Inc (CSI). G. Mintz, and A. Maehara are employed at the Cardiovascular Research Foundation (CRF) which receives funding from CSI. B. Martinsen is employed by CSI. M. Attubato and S. Zavlunova have nothing to disclose.

Figures

Figure 1.
Figure 1.
Angiography case example. A lesion in the mid to distal superficial femoral artery was treated with orbital atherectomy system (OAS; 2.0 mm Crown). The post-POBA flow was excellent. POBA indicates postoperative ballon angioplasty.
Figure 2.
Figure 2.
A representative case of pretreatment, post-orbital atherectomy system (OAS), and post-balloon angioplasty (BA) images. The lumen increased from pretreatment (4.2 mm2) to post-OAS (11.5 mm2) to post-BA (17.5 mm2). The circumference (red line) of calcium surface increased from pretreatment to post-OAS to post-BA.
Figure 3.
Figure 3.
A representative case of pretreatment, post-orbital atherectomy system (OAS) appearing reverberation. Panel A pretreatment and Panel B post-OAS were matched. Panel A and B correspond directly to Panel A’ and B’. Reverberation (red lines in A’ and B’) increased from pretreatment to post-OAS due to polished surface of calcified plaque. Blue dots = 1 mm scale.
See this image and copyright information in PMC

References

    1. Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992;86(1):64–70. - PubMed
    1. Schwarzwälder U, Zeller T. Debulking procedures: potential device specific indications. Tech Vasc Interv Radiol. 2010;13(1):43–53. - PubMed
    1. Safian RD, Niazi K, Runyon JP, et al. Orbital atherectomy for infrapopliteal disease: device concept and outcome data for the OASIS trial. Catheter Cardiovasc Interv. 2009;73(3):406–412. - PubMed
    1. Adams GL, Khanna PK, Staniloae CS, Abraham JP, Sparrow EM. Optimal techniques with the Diamondback 360° System achieve effective results for the treatment of peripheral arterial disease. J Cardiovasc Transl Res. 2011;4(2):220–229. - PubMed
    1. Das T, Mustapha J, Indes J, et al. Technique optimization of orbital atherectomy in calcified peripheral lesions of the lower extremities: the CONFIRM series, a prospective multicenter registry. Catheter Cardiovasc Interv. 2014;83(1):115–122. - PMC - PubMed

Publication types

MeSH terms

Associated data