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 : November 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease Vascular Disease Critical Limb Ischemia||Drug: Dexamethasone infusion Device: Drug coated balloon Device: Plain balloon angioplasty||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.
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 (Clinical Trial)|
|Actual Enrollment :||33 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|
Participants randomized to the Dexamethasone group will receive dexamethasone infusion to the adventitia of the artery following plain-old-balloon-angioplasty (POBA).
Drug: Dexamethasone infusion
Participants will receive dexamethasone infusion following plain balloon angioplasty
Other Name: microinfusion catheter
Active Comparator: Drug Coated Balloon
Participants 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
Participants will receive angioplasty with a drug-coated balloon following plain balloon angioplasty
Active Comparator: Plain Balloon Angioplasty
Participants randomized to the Plain Balloon Angioplasty will receive balloon angioplasty (POBA) only. They will not receive adventital dexamethasone or paclitaxel.
Device: Plain balloon angioplasty
Participants will receive plain balloon angioplasty only
- 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 .
- Extended Clinical Adverse Events Monitoring [ Time Frame: From Post-Operative Day One to 36 Months ]Participant monitoring for clinical adverse events
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|