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Diamondback in Peripheral Vascular Disease — DIAMOND-PAD  

Critical Limb Ischemia Clinical Trial

Official title:
Diamondback Atherectomy With OCT Visualization for Calcified PAD Lesions for Calcified Peripheral Vascular Disease Lesions

Clinical Trial Summary

This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if they have claudication and/or critical limb ischemia, and identifiable PAD disease with moderate to severe calcification on Computer Tomography Angiogram (PCA) or peripheral angiogram requiring percutaneous peripheral intervention (PPI).

Clinical Trial Description

Orbital atherectomy (OA) is one of the most commonly used modalities for the treatment of obstructive femoral-popliteal PAD, especially in patients with large and calcified atherosclerotic plaques, either as stand alone or with subsequent drug-coated balloon angioplasty or stent implantation. These atherectomy procedures were primarily guided by peripheral angiography which has significant resolution limitations in regards to the plaque morphology and characteristics such as extent of calcification, and how deep the cuts are made in the vessel wall.

Optical coherence tomography (OCT) has recently emerged as a novel imaging modality. OCT imaging has been used both in coronary as well as in peripheral circulation extensively with no significant device related adverse effects. Previous research has shown the feasibility and safety of OCT use for peripheral artery imaging and its use in plaque characterization. The hypothesis for this study is that; use of diamond back atherectomy device will lead to effective removal of plaque in moderate to heavily calcified arteries without damaging deep into the adventitia or EEL or the adjacent healthy vessel wall and thus will lead to a favorable vascular response during follow up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03455374
Study type Interventional
Source Arkansas Heart Hospital
Contact
Status Terminated
Phase N/A
Start date August 8, 2017
Completion date May 13, 2019
View Details
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