Clinical trial NCT06029491: The Pivotal Study of RapidPulseTM Aspiration System
Official title: The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Large Vessel Occlusion
Mechanical Thrombectomy
Neurovascular Intervention
Lead sponsor: RapidPulse, Inc
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participation in the trial is for 90 days.

Detailed description: The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by a central events committee (CEC).

Eligibility criteria: Inclusion Criteria:

* Age 18 to 80 years
* Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
* Able to be treated within 8 hours of symptom onset or last known normal (LKN)
* Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
* Pre-morbid Modified Rankin Scale (mRS) score 0-1
* Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration
* Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)

Exclusion Criteria:

* Intracranial Hemorrhage (ICH)
* Alberta Stroke Program Early CT Score (ASPECTS) \<6
* Intracranial Atherosclerotic Disease (ICAD)
* Multiple or tandem occlusions
* Life expectancy less than 6 months

Primary outcomes:
measure: Rate of First Pass Reperfusion Effect (FPE)
timeFrame: Intra-procedural
measure: Rate of symptomatic intracranial hemorrhage (sICH)
timeFrame: Post-procedural (24 hours post-thrombectomy)
Secondary outcomes:
measure: Rate of reperfusion after all study device passes
timeFrame: Intra-procedural
measure: Modified Rankin Scale (mRS) at 90 days post treatment
timeFrame: Post-procedure (90 days post-thrombectomy)
Other outcomes:
measure: Rate of modified First Pass Reperfusion Effect (mFPE) after one reperfusion attempt
timeFrame: Intra-procedural
measure: Final reperfusion effect
timeFrame: Intra-procedural
measure: Time to reperfusion
timeFrame: Intra-procedural
measure: Rate of major early neurological recovery
timeFrame: Post-procedure (24 hours post-thrombectomy)
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)
measure: Incidence of all cause mortality
timeFrame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)
measure: Incidence of device related vasospasm
timeFrame: Intra-procedural
measure: Incidence of embolism in new territory
timeFrame: Intra-procedural
measure: Incidence of all intracranial hemorrhage
timeFrame: Post-procedural (24 hours post-thrombectomy)
Locations:
city: Torrance
country: United States
facility: Providence Saint John's Medical Foundation
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University at Grady
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Aurora Research Institute
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Iowa City
country: United States
facility: State University of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: Buffalo
country: United States
facility: State University of New York at Buffalo
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Memphis
country: United States
facility: Semmes Murphey Foundation - Baptist Memorial Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Harlingen
country: United States
facility: Valley Baptist Medical Center - Harlingen
state: Texas
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d' Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Istanbul
country: Turkey
facility: Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi
Study officials:
affiliation: University of Pittsburgh Medical Center Stroke Institute
name: Raul G Nogueira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Vall d' Hebron
name: Marc Ribó, MD
role: PRINCIPAL_INVESTIGATOR
References: