Vascular-Interventional Clinical Trials
Cook IVC Filter Study (PI: Charles Burke)
Purpose: This prospective, multicenter, single-arm clinical study will further evaluate the safety and effectiveness of Cook’s permanent and retrievable inferior vena cava (IVC) filters (specifically, the Günther Tulip® and the Cook Celect® filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).
Participants: This study will enroll 320 patients in the Celect® filter stratum and up to 150 patients in the Günther Tulip® stratum at up to 40 clinical sites globally.
Procedures (methods): Patients will be stratified based upon the type of filter they receive, and enrollment will cease when 320 patients have been enrolled in the Celect® filter stratum.
Study assessments will include, but are not limited to: rate of technical placement success, rate of freedom from new symptomatic PE, rate of freedom from new PE, rate of clinical perforation, rate of migration, rate of filter fracture, rate of filter embolization, rate of IVC thrombotic occlusion, rate of deep vein thrombosis (DVT; total incidence and new incidence), rate of procedure-related complications, time to filter retrieval, number of successful retrievals, and rate of technical retrieval success.
OsteoCool Tumor Ablation Post-Market Study (OPuS One) (PI: Robert Dixon)
Purpose: To evaluate the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
Participants: Patients with metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum that are candidates for OsteoCool RF ablation per the labeled indication.
Procedures (methods): Prospective, multi-center, post-market, single-arm study. Each subject’s participation in the study is expected to last approximately 1 year from the date of the OsteoCool procedure. Follow-up assessments will occur upon discharge post procedure (worst pain only), 3 days, 1 week and 1-, 3-, 6-, and 12-months post procedure.
The overall study duration, from first subject enrollment to last subject visit, is expected to last approximately 5 years. The completion of the study is defined as the approval of the Final Study Report and closure of all sites.
LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study (PI: Ari Isaacson)
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: IPSS and QoL score changes, Qmax changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization.
Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study
Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
Geniculate Artery Embolization for the Treatment of Knee Pain Secondary to Osteoarthritis (PI: Ari Isaacson)
Purpose: The primary aims of this study are to determine if geniculate artery embolization (GAE) will reduce the severity of pain as well as global disability (resulting from the combination of pain, stiffness and difficulty performing daily activities) caused by knee OA and if it can be performed safely. The secondary aim is to determine if GAE can result in the decreased necessity for ongoing conservative OA therapies such as medication therapy and joint injections.
Participants: Twenty patients from UNC and the Vascular Institute of Virginia with knee osteoarthritis resulting in knee pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months.
Procedures (methods): This will be an open label 24-month pilot study with a small population undergoing GAE to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 1, 3 & 6 months. An MRI will be performed at the 1-month visit to detect a change in synovial vascularity and to exclude complication.
Randomized Placebo-Controlled Single Blinded Study of Geniculate Artery Embolization for Knee Pain Secondary to Osteoarthritis (PI: Ari Isaacson)
Purpose: To evaluate embolization as a treatment for OA related knee pain versus placebo to demonstrate the actual effect of embolization on pain and disability.
Participants: There will be 21 subjects enrolled over the age 40 with knee pain secondary to arthritis.
Procedures (methods): This will be a single-blinded randomized-controlled study of GAE versus placebo in a small population with knee pain secondary to arthritis to determine safety and efficacy. Clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 2 weeks, 1, 3, 6, and 12 months. An MRI will be performed after the 1-month visit in those patients who underwent embolization to detect a change in synovial vascularity and to exclude complication.
Safety and Efficacy of Prostatic Artery Embolization Using HydroPearl Embolic Particles (PI: Ari Isaacson)
Purpose: The purpose of this study is to determine review safety and efficacy data for patients who underwent prostatic artery embolization (PAE) with HydroPearl over the past year at UNC.
Participants: 25 adult male subjects with benign hyperplasia who had a PAE procedure between January 1, 2018 and December 31, 2018 will be enrolled in this study.
Procedures (methods): The analysis will review safety and efficacy data in EPIC from patients who underwent PAE with HydroPearl over the past year at UNC. In addition, patients who do not have follow-up data already recorded will be contacted by phone, email or mail to provide this information. Data collected will include age, medication, catherization, prostate volume baseline, baseline International Prostate Symptom Score + Quality of Life score (IPSS+QoL), unilateral vs bilateral embolization, size of particles used, complications and follow-up IPSS+QoL (if 2 months has passed since PAE). The follow up interval will be at 1 month, 3 month, 6 month and 12 month.