March 4, 2020
Thrombolex FIH Trial Supports Early Safety and Feasibility of the Bashir Catheter for Acute PE
March 5, 2020—Thrombolex, Inc., which is focused on endovascular therapies for the treatment of arterial and venous thromboembolic disorders, announced that its first-in-human (FIH) trial confirms the early safety and feasibility of the company's Bashir endovascular catheter for pharmacomechanical catheter-directed thrombolysis (CDT) in patients with acute pulmonary embolism (PE). Additionally, the data showed a significant reduction in right ventricular to left ventricular (RV/LV) diameter ratio and clot burden.
The data were presented at the AVF 2020, the annual meeting of the American Venous Forum held March 3–6 in Amelia Island, Florida.
Conducted under an FDA investigational new drug assignment, the Thrombolex FIH trial was a prospective, single-arm, multicenter study that evaluated the safety and feasibility of the Bashir device in the treatment of patients with acute PE. The study enrolled nine patients at four centers in the United States.
According to the company, the study demonstrated the Bashir catheter's safety, as there were no drug- or device-related adverse events adjudicated by the data safety monitor.
The primary feasibility endpoints were met with a significant mean reduction in RV/LV diameter ratio. The RV/LV ratio decreased from 1.52 ± 0.26 preprocedure to 0.97 ± 0.06 (P = .0009), corresponding to a 36.7 % reduction at 48 hours after intervention.
The Modified Miller Index (MMI) demonstrated a decrease from 25.4 ± 5.3 preprocedure to 16 ± 4.0 at 48 hours postprocedure (P = .0005), corresponding to a 37.1% reduction, after a mean dose of 13.6 mg of recombinant tissue plasminogen activator (r-tPA) over 8 hours.
Both the reduction in RV/LV ratio and the reduction in clot burden as measured by the MMI score compare very favorably with what has been published in ultrasound-assisted CDT and mechanical thrombectomy device trials. This study will be followed by a much larger pivotal trial in patients with acute PE.
In the company's press release, the study's coprincipal investigator Akhilesh Sista, MD, commented, "The results from the [FIH] study for the Bashir endovascular catheter are exciting—the PE patients treated were real-world patients [who] had high thrombus burden and major right ventricular dilation. The amount of thrombus removed with less than 14 mg of r-tPA was impressive. I look forward to seeing what this device can do in a larger study and a randomized cohort." Dr. Sista is Chief of Vascular and Interventional Radiology at NYU-Langone School of Medicine in New York, New York.
Kenneth Rosenfield, MD, the Thrombolex FIH study's coprincipal investigator, added, “The innovative design of the Bashir endovascular catheter enables it to engage and fissure the thrombus, as well as deliver fibrinolytic throughout the entire cross-sectional volume of the clot. In theory, this potentially allows for more prompt restoration of flow to the lungs and relief of right ventricular overload. The results of this early feasibility study appear to corroborate this mechanism of action. We look forward to further evidence of this effect in a larger cohort.” Dr. Rosenfield is Cofounder of the PERT (pulmonary embolism response team) Consortium and interventional cardiologist and Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts.