The Pivotal Study of RapidPulseTM Aspiration System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RapidPulseTM Aspiration System.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Spain, Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions
Overview
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).
Interventions
- Device RapidPulseTM Aspiration System
The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the occluded cerebral vasculature using precisely pulsed aspiration. The system is comprised of the multi-use, non-sterile RapidPulseTM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter.
Primary outcome measures
- Rate of First Pass Reperfusion Effect (FPE) [Time frame: Intra-procedural]
- Rate of symptomatic intracranial hemorrhage (sICH) [Time frame: Post-procedural (24 hours post-thrombectomy)]
Secondary outcome measures (2)
- Rate of reperfusion after all study device passes [Time frame: Intra-procedural]
- Modified Rankin Scale (mRS) at 90 days post treatment [Time frame: Post-procedure (90 days post-thrombectomy)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- Providence Saint John's Medical Foundation — Torrance
- Yale University — New Haven
- Baptist Health Research Institute — Jacksonville
- University of South Florida — Tampa
- Emory University at Grady — Atlanta
- Rush University Medical Center — Chicago
- Advocate Aurora Research Institute — Park Ridge
- Indiana University Health — Indianapolis
- … and 10 more centers
Spain · 8 centers
- Hospital General Universitario Dr. Balmis — Alicante
- Hospital Universitari Germans Trias i Pujol — Badalona
- Hospital Universitari Vall d' Hebron — Barcelona
- Hospital Universitari de Bellvitge — Barcelona
- Hospital Universitari de Girona Dr. Josep Trueta — Girona
- Hospital Universitario de la Princesa — Madrid
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario La Paz — Madrid
France · 3 centers
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux
- Centre Hospitalier Universitaire de Montpellier — Montpellier
- Centre Hospitalier Universitaire de Toulouse — Toulouse
Turkey (Türkiye) · 1 center
- Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi — Istanbul
Identifiers
NCT: NCT06029491 · CIP-0002