Condition or disease | Intervention/treatment | Phase |
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Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Nervous System Diseases Pathologic Processes Stroke, Ischemic Stroke, Acute Vascular Diseases | Device: Mechanical Thrombectomy using the pRESET Thrombectomy device Device: Mechanical Thrombectomy using the Solitaire Revascularization Device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 316 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, multi-center randomized |
Masking: | Single (Outcomes Assessor) |
Masking Description: | The blinded assessor performs all study assessments during and after hospital discharge (i.e., 24 hours, Day 7/Discharge (whichever is earlier), and 30 and day 90 visits |
Primary Purpose: | Treatment |
Official Title: | pRESET for Occlusive Stroke Treatment |
Actual Study Start Date : | October 4, 2019 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
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Experimental: pRESET Thrombectomy Device
Mechanical Thrombectomy using the pRESET Thrombectomy Device
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Device: Mechanical Thrombectomy using the pRESET Thrombectomy device
Clot removal using the pRESET Thrombectomy device
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Active Comparator: Solitaire Revascularization Device
Mechanical Thrombectomy using the Solitaire Revascularization Device
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Device: Mechanical Thrombectomy using the Solitaire Revascularization Device
Clot removal using the Solitaire Revascularization Device
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Expanded Thrombolysis in Cerebral Infarction (eTICI) 0-1 flow confirmed by angiography that is accessible to the mechanical thrombectomy device in the following locations:
Note: M1 segment of the MCA is defined as the arterial trunk from its origin at the ICA to the first bifurcation or trifurcation into major branches neglecting the small temporo-polar branch.
Imaging scores as follows:
· ASPECTS score must be 6-10 on NCCT or DWI-MRI.
If automated core volume assessment software is used:
Exclusion Criteria:
Angiographic evidence of carotid dissection
Imaging exclusion criteria:
Contact: Gary Brogan | +35391740103 | gary.brogan@phenox.ie |
Principal Investigator: | Raul G Nogueira, MD | Grady Memorial Hospital | |
Principal Investigator: | Richardo A Hanel, MD | Baptist Medical Center, Jacksonville |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 24, 2019 | ||||||
First Posted Date ICMJE | June 21, 2019 | ||||||
Last Update Posted Date | April 21, 2021 | ||||||
Actual Study Start Date ICMJE | October 4, 2019 | ||||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | pRESET for Occlusive Stroke Treatment | ||||||
Official Title ICMJE | pRESET for Occlusive Stroke Treatment | ||||||
Brief Summary | Compare the safety and effectiveness of pRESET to Solitaire in the treatment of stroke related to large vessel occlusion | ||||||
Detailed Description | To determine the safety and effectiveness of pRESET for the treatment of acute ischemic stroke within 8 hours of symptom onset (defined as time patient was last seen well) due to large vessel occlusion and to compare safety and effectiveness to the predicate device, Solitaire™ Platinum revascularization device | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective, multi-center randomized Masking: Single (Outcomes Assessor)Masking Description: The blinded assessor performs all study assessments during and after hospital discharge (i.e., 24 hours, Day 7/Discharge (whichever is earlier), and 30 and day 90 visits Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
316 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 2021 | ||||||
Estimated Primary Completion Date | September 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Germany, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03994822 | ||||||
Other Study ID Numbers ICMJE | pCT-001-19 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | phenox Inc. | ||||||
Study Sponsor ICMJE | phenox Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | phenox Inc. | ||||||
Verification Date | April 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |