Oncology

DOORWAY 90 Study

A prospective, multicenter, open-label single arm study evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres ™ Y-90 resin microspheres on duration of response(DoR) and objective responses rate (ORR) in unrespectable hepatocellular carcinoma (HCC) patients.
Principal Investigator: Ripal Gandhi, M.D.
Activation Date: October 2021
 

HOPE4LIVER CSP1427

A single-arm, non-randomized prospective trial using the HistoSonics System for treatment of primary and metastatic liver tumors using histotripsy (#HOPE4LIVER US). Patient Profile: Patients with primary or metastatic liver tumors. Clinical and Scientific Relevance: The objective of this trial is to evaluate the safety and efficacy of the HistoSonics System for the treatment of primary or metastatic tumor located in the liver.
Principal Investigator: Govindarajan Narayanan, M.D.
Activation Date: October 2021

Peripheral Vascular Disease

STRIDE ALI

A post-market, real world, prospective, single-arm, multi-center study looking at patients that present with Lower Extremity Acute Limb Ischemia LE ALI who are eligible for mechanical thrombectomy using the Indigo Aspiration System. The Indigo Aspiration System is a medical device approved by the FDA to treat LE ALI. This study will collect real world outcomes data from the daily use of the device.
Principal Investigator: Alex Powell, M.D.
Activation Date: September 2020

Vascular Disease

BOLT DVT

A prospective, single-arm, multi center study of patients with deep vein thrombosis to evaluate the safety and efficacy of the Indigo™ Aspiration System in patients with deep vein thrombosis (DVT).
Study objective is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.
Principal Investigator: Constantino Pena, M.D.

Sub-Investigators: Ripal Gandhi, M.D., Andrew Niekamp, M.D., Brian Schiro, M.D., Alex Powell, M.D.

Activation Date: March 2022
 

SAVVE

A prospective, non-blinded, single-arm multi-center pivotal study of the Hancock Jaffe VenoValve. The valve is a monocuspid biological component mounted in a rigid supporting metal frame. The biological component comprises of a porcine aortic valve noncoronary leaflet as the functional component of the VenoValve with a section of aorta and a porcine mitral valve anterior leaflet stitched together as the supporting wall. Adult with chronic, axial deep venous reflux (CEAP Class C4b, C4c, C5 or C6) secondary to previous deep venous thrombosis (post-thrombotic syndrome) or primary reflux who have failed at least 3 months of standard care including compression therapy, and in C6 patients, wound care. All patients will receive optimized care (e.g., appropriate medications, compression therapy) throughout the study.
Principal Investigator: Michele Taubman, M.D.
Activation Date: November 2021
 

JAGUAR

Objective Analysis to GaUge EVAR Outcomes Through Randomization. Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Objective of this post-approval study is to collect safety, performance, effectiveness, and neck dilatation data on Alto Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms and evaluate real-world outcomes in comparison to commercially available comparator devices.
Principal Investigator: Constantino Pena, M.D.
Activation Date: May 2022

 

Abdominal Aortic Aneurysm

Gore Excluder AAA

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms. Prospective, multicenter, non-randomized clinical study with two parallel substudies designed to evaluate the safety and effectiveness of the CEXC Device for the treatment of infrarenal AAA in patients with Short Neck and highly angulated infrarenal aortic necks.
Principal Investigator: Alex Powell, M.D. (Active Enrollment)

Co-investigators: Barry Katzen M.D., Constantino Peña, M.D., Ripal Gandhi, M.D., Libby Watch, M.D., Brian Schiro, M.D.
 

Carotid Artery Disease

CREST-2

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) and Crest-2 Registry (C2R).
Principal Investigator: Barry Katzen, M.D. (Active Enrollment)
Co-investigators: Athanassios Tsoukas, M.D., Ian Del Conde Pozzi, M.D., Guilherme Dabus, M.D., Italo Linfante, M.D.
Activation Date: June 2015

Pulmonary Embolism Trials

STRIKE-PE

A prospective,multicenterstudyoftheIndigoaspirationsystemseekingtoevaluatethelong-termsafetyandoutcomesoftreatingpulmonaryembolism

Patient Profile: Patients with acute pulmonary embolism. 

Clinical and Scientific Relevance: Study objective is to evaluate real world long-term functional outcomes, safety and performance data of the Indigo Aspiration System for the treatment of pulmonary embolism (PE) 

Principal Investigator: Brian Schiro,MD 

Activation Date: December 2021

PEERLESS

A prospective, multicenter, randomized controlled trial of the Flow Triever System compared to CDT for acute intermediate-high-risk PE, and includes a non-randomized cohort for subjects with an absolute contraindication to thrombolytics.
Patient Profile: Patients with acute intermediate high risk pulmonary embolism.

Clinical and Scientific Relevance: Primary objective is to compare the clinical outcomes of patients treated with the Flow Triever System versus Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute intermediate-high-risk pulmonary embolism (PE).


Principal Investigator: Ripal Gandhi, MD

Activation Date: June 2022