Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging (INVADER MRI)
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|ClinicalTrials.gov Identifier: NCT02807779|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2016
Last Update Posted : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease Vascular Disease Critical Limb Ischemia||Drug: Dexamethasone infusion Device: Drug coated balloon||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging|
|Actual Study Start Date :||February 10, 2016|
|Actual Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||October 2022|
Patients randomized to the Dexamethasone group will receive dexamethasone infusion to the adventitia of the artery following plain-old-balloon-angioplasty (POBA).
Drug: Dexamethasone infusion
Patients will receive dexamethasone infusion following plain balloon angioplasty
Other Name: microinfusion catheter
Active Comparator: Drug Coated Balloon
Patients randomized to the Drug Coated Balloon (DCB) group will not receive dexamethasone infusion to the adventitia of the artery following (POBA). They will receive additional angioplasty with a paclitaxel coated balloon.
Device: Drug coated balloon
Patients will receive angioplasty with a drug-coated balloon following plain balloon angioplasty
- Change in Percent Wall Volume (PWV) [ Time Frame: From Post-Operative Day One to 12 Months ]Percent Wall Volume (PWV) of the treated segment of artery will be measured by MRI.
- Change in wall volume (WV) without a change in total vessel volume (TVV) [ Time Frame: From Post-Operative Day One to 12 Months ]As measured by MRI
- Change in perioperative inflammatory profile (MCP-1) [ Time Frame: From Post-Operative Day One to 12 Months ]As measured by serum MCP-1
- Change in perioperative inflammatory profile (CRP) [ Time Frame: From Post-Operative Day One to 12 Months ]As measured by serum CRP
- Change in perioperative inflammatory profile (IL-1beta) [ Time Frame: From Post-Operative Day One to 12 Months ]As measured by serum IL-1beta
- Change in ktrans [ Time Frame: From 1 Month to 6 Months ]As measured by MRI
- Change in lumen volume (LV) relative to total vessel volume (TVV) [ Time Frame: From Post-Operative Day One to 12 Months ]As measured by MRI
- Percentage of subjects with clinically significant restenosis that undergo reintervention of greater than or equal to 75% of the treated segment [ Time Frame: From Post-Operative Day One to 12 Months ]As the subject undergoes reintervention, any treatment that overlaps with greater than or equal to 75% of the segment initially treated by the index procedure (treated segment) may result in obfuscation of the primary outcome measure .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807779
|United States, California|
|San Francisco VA Medical Center|
|San Francisco, California, United States, 94121|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Warren Gasper, MD||San Francisco VA Medical Center|
|Principal Investigator:||David Saloner, PhD||San Francisco VA Medical Center|