| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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
|
Device: Mechanical Thrombectomy using the Solitaire Revascularization Device
Clot removal using the Solitaire Revascularization Device
|
| 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 |
Show 21 study locations
| Principal Investigator: | Raul G Nogueira, MD | Grady Memorial Hospital | |
| Principal Investigator: | Richardo A Hanel, MD | Baptist Medical Center, Jacksonville |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||||
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* 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 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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