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 : Recruiting
First Posted : June 21, 2016
Last Update Posted : December 8, 2017
|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|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
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
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
|Contact: Sukaynah Khetani||415-353-4368||Sukaynah.email@example.com|
|Contact: David Cheng||415-750-2115 ext 24708||David.firstname.lastname@example.org|
|United States, California|
|San Francisco VA Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Sukaynah Khetani 415-353-4368 email@example.com|
|Contact: David Cheng 415-750-2115 ext 24708 firstname.lastname@example.org|
|Principal Investigator: Warren Gasper, MD|
|Principal Investigator: David Saloner, PhD|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Kristi Pimentel 206-616-2023 email@example.com|
|Principal Investigator: Thomas Hatsukami, MD|
|Principal Investigator:||Warren Gasper, MD||San Francisco VA Medical Center|
|Principal Investigator:||David Saloner, PhD||San Francisco VA Medical Center|