Clinical Research Trials

The WakeMed Clinical Research Institute (CRI) conducts human studies (clinical trials) of the most promising new treatments and advances in many medical conditions, including heart and vascular disease.

Many study participants receive no-cost medical exams and ongoing assessments and diagnostic testing, no-cost study medications and medical devices, and financial compensation and/or travel reimbursement.

WakeMed is currently conducting a number of clinical trials looking at heart and vascular disease, including:

• TEAMS—Is an investigator-initiated trial to determine whether application of HEMOBLASTTM Bellows during on pump sternotomy surgeries in patients with high risk for bleeding reduces sternal bleeding. (Dr. Judson Williams)
• CSP-- Study to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). (Drs. Ellen Dillavou, Christopher McQuinn and Kirk Charles)
• LEAAPS (Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction)—Trial to demonstrate the effectiveness of LAA exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke. (Drs. Williams and Upham)
• PSR (Product Surveillance Registry)-- Serve as an ongoing source of product performance, patient safety and clinical outcomes information associated with the use of pacemaker and defibrillator market released products. (Dr. Marc Silver)
• BACKBEAT—Trial to evaluate the safety and effectiveness of a novel AV interval modulation (AVIM) algorithm downloaded into dual-chamber Medtronic pacemaker in patients with uncontrolled hypertension despite medical therapy. (Drs. Marc Silver and Mark Englehardt)
• PREVENA AMP—A trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications, and medical costs in patients undergoing lower extremity amputation. (Drs. Ellen Dillavou and Kirk Charles)
• VENOSTENT – Trial to evaluate the safety and efficacy of the SelfWrap device in chronic kidney disease (CKD) patients referred for arteriovenous fistula (AVF) creation surgery. (Drs. Ellen Dillavou and Kirk Charles)
• EASi-HF – A trial to evaluate efficacy and safety of the combined use of oral vicadrostat and empagliflozin compared with placebo and empagliflozin in participants with symptomatic heart failure (NYHA class II to IV) and LVEF ≥40%. (Drs. Kishan Parikh and Stuart Russell)
• TiGER – A registry to collect real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice. (Drs. Christopher McQuinn, Kirk Charles, Ellen Dillavou, Joseph Salfity, Trevor Upham, Judson Williams).
• DeciPHer-ILD – A study is to observe and capture demographic characteristics, treatment patterns, and clinical outcomes of interest for patients with PH-ILD (pulmonary hypertension associated with interstitial lung disease) to further clinical understanding of the epidemiological landscape and outcomes of the disease and treatment. (Dr. Kishan Parikh)
• AcoArt- Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt LitosTM Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients with Chronic Limb-Threatening Ischemia. (Dr. Siva Ketha)
• Prevena 14-Day- This is a prospective, single-arm, multicenter, open-label study that will enroll Subjects requiring an incision for 1 of 4 types of surgery (abdominal surgery or C-section, vascular surgery, cardiothoracic surgery requiring median sternotomy, or lower extremity orthopedic surgery). Data collected in this study using a Prevena Plus Incision Management System with Prevena Dressings for up to 14 days will be compared with the 7-day safety data derived from a meta-analysis based on the prevailing literature including 3 previous RCTs in which the Prevena Incision Management System (with Prevena Dressings) was applied for up to 7 days. (Drs. Judson Williams/Kirk Charles/Ellen Dillavou/ Christina Bull, NP)
• SIMPLAAFY- This study is a prospective, randomized, open-label, triple-arm, multicenter trial. Subjects will be randomized 1:1:1 to one of the three protocol defined drug regimens and will remain on treatment through the end of study (12-months):

1. Aspirin only for entire 12-month study duration
2. Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC), either commercially available apixaban (preferred) or rivaroxaban for first 3-months, followed by aspirin
3. DAPT (aspirin + clopidogrel) for first 6-months, followed by aspirin only (Dr. Ashish Patel and Dr. Kevin Manocha)

• OMNY-AF- Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation with the BWI Pulsed Field Ablation System with OMNYPULSE™ Catheter (Dr. Ashish Patel and Dr. Kevin Manocha)
• Agent- IDE- A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis (ISR) (Dr. Damien Marycz)
• PSR-APV- (Product Surveillance Registry- Aortic, Peripheral, Venous)-- Serve as an ongoing source of product performance, patient safety and clinical outcomes information associated with the use of peripheral and venous drug coated balloons and stent systems for market released products. (Dr. Siva Ketha)

Talk with your doctor if you are interested in participating in a clinical trial.