A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2014 by Penumbra Inc.
Sponsor:
Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01584609
First received: April 23, 2012
Last updated: November 6, 2014
Last verified: November 2014
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Purpose
This is a prospective, randomized, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (>3mm in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 164 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Ischemic Stroke From Large Vessel Occlusion |
Device: Penumbra System with Separator 3D Device: Penumbra System alone |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke |
Further study details as provided by Penumbra Inc.:
Primary Outcome Measures:
- Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TIMI/TICI score of 2 or 3 [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: No ]
- Incidence of device-related and procedure-related serious adverse event [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Good clinical outcome at 30 days post-procedure as defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1at Discharge; or a 30-day mRS score of 0-2 [ Time Frame: 30 days post-procedure ] [ Designated as safety issue: No ]
- The proportion of patients with a modified Rankin Scale (mRS) of ≤ 2 at 90 days post treatment [ Time Frame: at 90 days post-procedure ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: At 90 days post-procedure ] [ Designated as safety issue: Yes ]
- Incidence of symptomatic hemorrhage [ Time Frame: At 90 days post-procedure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 230 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Penumbra System with Separator 3D |
Device: Penumbra System with Separator 3D
The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
| Active Comparator: Penumbra System alone |
Device: Penumbra System alone
The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- From 18 to 85 years of age
- Present with symptoms consistent with an acute ischemic stroke for revascularization within 8 hours from symptom onset
- Refractory to or not eligible for IV rtPA therapy
- Evidence of a large vessel (3mm or greater in diameter) occlusion in the cerebral circulation
- NIH Stroke Scale (NIHSS) score 8 or more points
- Signed informed consent
Exclusion Criteria:
- History of stroke in the past 3 months.
- Females who are pregnant
- Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score 1 or higher
- Known severe allergy to contrast media
- Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)
-
CT evidence of the following conditions at randomization:
- Significant mass effect with midline shift
- Large infarct region >1/3 of the middle cerebral artery territory
- Evidence of intracranial hemorrhage
- Angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal
- Angiographic evidence of preexisting arterial injury
- Rapidly improving neurological status prior to enrollment
- Bilateral stroke
- Intracranial tumors
- Known history of cerebral aneurysm or arteriovenous malformation
- Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >1.7
- Baseline platelets <50,000
- Use of IV heparin in the past 48 hours with PPT >1.5 times the normalized ratio
- Baseline glucose <50mg/dL or >300mg/dL
- Life expectancy less than 90 days prior to stroke onset
- Participation in another clinical investigation that could confound the evaluation of the study device
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584609
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584609
Contacts
| Contact: Elan Mualem, BS | 510-748-3254 | elan.mualem@penumbrainc.com | |
| Contact: Siu P Sit, PhD | 510-748-3221 | siupo.sit@penumbrainc.com |
Locations
| United States, California | |
| Hoag Hospital | Recruiting |
| Newport Beach, California, United States, 92658 | |
| Contact: Laura Whitaker 949-764-8190 laura.whitaker@hoaghospital.org | |
| Contact: Wallace Peck, MD 949-764-8190 wpneurorad@aol.com | |
| Principal Investigator: Wallace Peck, MD | |
| United States, Colorado | |
| Swedish Medical Center | Recruiting |
| Denver, Colorado, United States, 80112 | |
| Contact: Gwen Dooley 303-757-3525 Gwendolyn.dooley@riaco.com | |
| Contact: Ita Dempsey, RN 720-493-3406 don.frei@riaco.com | |
| Principal Investigator: David Loy, MD | |
| United States, Connecticut | |
| Hartford Hospital | Recruiting |
| Hartford, Connecticut, United States, 6106 | |
| Contact: Martha Ahlquist 860-545-6047 Mahlqui@harthosp.org | |
| Contact: Linda Adams 860-545-5611 ladams@harthosp.org | |
| Principal Investigator: Gary Spiegel, MD | |
| Sub-Investigator: Stephen Ohki, MD | |
| Sub-Investigator: Martin Ollenschleger, MD | |
| United States, Georgia | |
| Grady Health System | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Kiva Schindler, RN, CCRC 404-778-1571 kiva.m.schindler@emory.edu | |
| Principal Investigator: Raul Nogueira, MD | |
| Sub-Investigator: Rishi Gupta, MD | |
| United States, Minnesota | |
| St. Joseph Hospital- Healtheast | Recruiting |
| St. Paul, Minnesota, United States, 55102 | |
| Contact: Sandy Bartz 651-726-6458 sbartz@stpaulrad.com | |
| Contact: Michael Madison, MD 612-860-2436 mmadison@stpaulrad.com | |
| Principal Investigator: Michael Madison, MD | |
| United States, New York | |
| Kaleida Health | Recruiting |
| Buffalo, New York, United States, 14209 | |
| Contact: Jennifer Gay 716-218-1000 ext 5111 jgay@ubns.com | |
| Principal Investigator: Adnan Siddiqui, MD/PhD | |
| Sub-Investigator: Elad Levy, MD | |
| Stony Brook University Hospital | Recruiting |
| Stony Brook, New York, United States, 11794-8122 | |
| Contact: Marlene Baumeister, RN, BSN, CCRC, CNRN 631-444-1610 mbaumeister@notes.cc.sunysb.edu | |
| Contact: Dawn Madigan, RN, BSN,CCRC 631-444-8121 Dawn.Madigan@sbumed.org | |
| Principal Investigator: David Fiorella, MD | |
| Principal Investigator: Henry Woo, MD | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Bree Burks 615-875-7606 bree.burks@Vanderbilt.Edu | |
| Principal Investigator: J Mocco, MD | |
Sponsors and Collaborators
Penumbra Inc.
Investigators
| Principal Investigator: | Don Frei, MD | Swedish Medical Center, Denver, CO |
More Information
No publications provided
| Responsible Party: | Penumbra Inc. |
| ClinicalTrials.gov Identifier: | NCT01584609 History of Changes |
| Other Study ID Numbers: | CLP 4853, CLP 4853 |
| Study First Received: | April 23, 2012 |
| Last Updated: | November 6, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Penumbra Inc.:
|
ischemic stroke large vessel occlusion mechanical thrombectomy |
revascularization Penumbra System Separator 3D |
Additional relevant MeSH terms:
|
Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases |
Cerebrovascular Disorders Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015