Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease (DANCE)
To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries.
Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel treatment length.
|Peripheral Arterial Diseases||Drug: Dexamethasone Sodium Phosphate Injection, USP||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization|
- MALE-POD [ Time Frame: 30 days ]Acute safety safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of Major Adverse Limb Events or Peri-Operative Death (MALE+POD) within 30 days from the procedure for all subjects.
- Duplex ultrasound index lesion binary restenosis [ Time Frame: 6 months ]Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.
- Duplex ultrasound index lesion binary restenosis [ Time Frame: 12 months ]Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.
- Long term safety [ Time Frame: 30 days to 6 months ]Long term safety outcomes that occur after 30 days through 6 months post-procedure will be determined by evaluating adverse events.
- Duplex ultrasound index lesion flow limiting restenosis [ Time Frame: 6 and 12 months ]Flow limiting restenosis will be judged by core laboratory as PSVR>4.0.
- Change in inflammatory biomarkers [ Time Frame: Baseline and 24 hours ]Change in inflammatory biomarkers will be measured with a panel of biomarkers in 1/3 of patients.
- Vascular patency [ Time Frame: 6, 12, 18 and 24 months ]Target lesion revascularization (TLR) rate, target extremity revascularization (TER) rate, limb salvage rate and primary patency (PSVR≤2.4 and no TLR) at 6, 12, 18 and 24 months. Note: provisional stenting performed during the index procedure shall not be considered to be TLR, TER or loss of primary patency.
- Clinical outcome measures [ Time Frame: 1, 6, 12, 18 and 24 months ]Modified Walking Impairment Questionnaire, Ankle-Brachial Index, Rutherford Score.
- Infusion Technical Success [ Time Frame: Intraprocedural ]Distribution grade around infusion sites.
- Procedural Success [ Time Frame: Intraprocedural ]Establishment of antegrade flow with residual stenosis of <30% by angiogram.
- Healthcare Economics [ Time Frame: 30 days ]Number of return visits and hospitalizations, time from index procedure to required revascularization and number of index-lesion-related readmissions within 30 days will be measured.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Adventitial Dexamethasone
In patients receiving either angioplasty or atherectomy-based revascularization (pre-stratified to each by 50% of the total study), dexamethasone will be delivered to the adventitia following revascularization.
Drug: Dexamethasone Sodium Phosphate Injection, USP
Adventitial infusion of dexamethasone after angioplasty or atherectomy-based revascularization of the superficial femoral or popliteal artery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01983449
Show 38 Study Locations
|Principal Investigator:||Mahmood Razavi, MD||St. Joseph's Vascular Institute|