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NCT Number: NCT06029491

The Pivotal Study of RapidPulseTM Aspiration System

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RapidPulseTM Aspiration System

Device

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.

Other names: Aspiration Thrombectomy, Thrombectomy

Primary outcomes

  1. Rate of First Pass Reperfusion Effect (FPE)

    Time frame: Intra-procedural

    The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass

  2. Rate of symptomatic intracranial hemorrhage (sICH)

    Time frame: Post-procedural (24 hours post-thrombectomy)

    The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy

Secondary outcomes

  1. Rate of reperfusion after all study device passes

    Time frame: Intra-procedural

    Proportion of patients who achieve mTICI ≥ 2b within a maximum of 3 passes with Study Device

  2. Modified Rankin Scale (mRS) at 90 days post treatment

    Time frame: Post-procedure (90 days post-thrombectomy)

    Proportion of patients who achieve mRS ≤2 at 90-days post treatment.

Other outcomes

  1. Rate of modified First Pass Reperfusion Effect (mFPE) after one reperfusion attempt

    Time frame: Intra-procedural

    Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass

  2. Final reperfusion effect

    Time frame: Intra-procedural

    Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion

  3. Time to reperfusion

    Time frame: Intra-procedural

    Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment.

  4. Rate of major early neurological recovery

    Time frame: Post-procedure (24 hours post-thrombectomy)

    Proportion of patients with major early neurological recovery at 24-hours as defined by reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of at least 8 points or reaching NIHSS 0-1.

    *NIHSS ranges from 0 to 42, with higher scores indicating greater neurological deficit.

  5. Incidence of Serious Adverse Events (SAEs)

    Time frame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)

    All device-related and procedure-related serious adverse events

  6. Incidence of all cause mortality

    Time frame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)

    All-cause mortality assessed through 90 days post index procedure.

  7. Incidence of device related vasospasm

    Time frame: Intra-procedural

    Device-related vasospasm

  8. Incidence of embolism in new territory

    Time frame: Intra-procedural

    Embolism in new territory determined based on procedural angiogram

  9. Incidence of all intracranial hemorrhage

    Time frame: Post-procedural (24 hours post-thrombectomy)

    Any intracranial hemorrhage according to the Heidelberg classification at 24-hours

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Yang

CONTACT

[email protected]

9498367402

Sponsors and collaborators

Lead sponsor

RapidPulse, Inc

Industry

Registry information

Official study title

The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions

Acronym: PIVOTAL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2023
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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