This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the leg.
Peripheral artery disease (PAD) affects at least 12 million Americans annually with more than half a million patients undergoing an endovascular or surgical revascularization procedure in order to treat the disease. Unfortunately, about two-thirds of patients still have blockages in the leg arteries, even after these procedures. Advances in Magnetic resonance imaging (MRI) offer promise for understanding the mechanism of failure through insights into vessel wall composition, remodeling, and inflammation. Restenosis has a known relationship to inflammation. Advances in micro-catheter technologies offer the ability to deliver anti-inflammatory medications such as Dexamethasone (DEX) directly to the adventitia and advances in drug delivery on balloon surfaces to deliver paclitaxel to the intima of the artery. This study aims to investigate if patient-specific parameters affect angioplasty outcomes, if DEX has a biological effect on the vessel wall, and if this effect is through the reduction of inflammation. In response to an FDA issued "Letter to Healthcare Providers" dated August 9, 2019 that reported the "relative risk for increased mortality at 5 years was 1.57 (95% confidence interval 1.16 - 2.13), which corresponds to a 57% relative increase in mortality in patients treated with paclitaxel-coated devices," participant enrollment in the paclitaxel drug coated balloon arm was stopped and a plain balloon angioplasty arm was added to the protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
33
Participants will receive dexamethasone infusion following plain balloon angioplasty
Participants will receive angioplasty with a drug-coated balloon following plain balloon angioplasty
Participants will receive plain balloon angioplasty only
San Francisco VA Medical Center
San Francisco, California, United States
University of Washington
Seattle, Washington, United States
Change in Percent Wall Volume (PWV)
The change in percent wall volume (PWV) of the treated segment between the postoperative and 12 month time points as measured by MRI
Time frame: From Post-Operative Day One to 12 Months
Change in Wall Volume (WV) Without a Change in Total Vessel Volume (TVV)
The change in wall volume (WV) without change in total vessel volume (TVV) of the treated segment between the postoperative and 12 month time points as measured by MRI
Time frame: From Post-Operative Day One to 12 Months
Change in Perioperative Inflammatory Profile (MCP-1)
The serum concentration of monocyte chemoattractant protein-1 (MCP-1) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the MCP-1 concentration (postprocedure day 1, 1 month and 12 months)
Time frame: From Post-Operative Day One to 12 Months
Change in Perioperative Inflammatory Profile (CRP)
The serum concentration of C-reactive protein (CRP) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the CRP concentration (postprocedure day 1, 1 month and 12 months).
Time frame: From Post-Operative Day One to 12 Months
Change in Perioperative Inflammatory Profile (IL-1beta)
The serum concentration of interleukin-1beta (IL-1beta) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the IL-1beta concentration (postprocedure day 1, 1 month and 12 months).
Time frame: From Post-Operative Day One to 12 Months
Change in Transfer Constant (Ktrans)
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The change in adventitial transfer constant (Ktrans) of the treated segment between the postoperative and 6 month time points as measured by dynamic contrast enhanced MRI
Time frame: From 1 Month to 6 Months
Change in Lumen Volume (LV) Relative to Total Vessel Volume (TVV)
The change in lumen volume (LV) relative to total vessel volume (TVV) of the treated segment between the postoperative and 12 month time points as measured by MRI
Time frame: From Post-Operative Day One to 12 Months
Percentage of Subjects With Clinically Significant Restenosis That Undergo Reintervention of Greater Than or Equal to 75% of the Treated Segment
Percentage of subjects with clinically significant restenosis that undergo reintervention of greater than or equal to 75% of the treated segment by the 12 month timepoint.
Time frame: From Post-Operative Day One to 12 Months