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This study is designed to evaluate the effectiveness, safety and clinical performance of ADAPT 2.0, first-line aspiration neurothrombectomy with Zoom System with Continuous Dual Aspiration Technique (CDAT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADAPT 2.0: Zoom System with Continuous Dual Aspiration Technique (CDAT) | The Zoom System is intended to be used as the first-line device and utilized within the FDA-cleared indications for use, consistent with the approved labeling and intended anatomical targets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoom System | Device | Aspiration neurothrombectomy using Zoom System with Continuous Dual Aspiration Technique (CDAT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2c at the end of procedure, as adjudicated by independent core-lab | mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion. mTICI 0: No antegrade reperfusion; mTICI 1: Antegrade reperfusion past initial occlusion, limited distal filling; mTICI 2a: Antegrade reperfusion of less than half (<50%) of the previously occluded target artery's ischemic territory; mTICI 2b: Antegrade reperfusion of more than half (≥50%) of the previously occluded target artery's ischemic territory; mTICI 2c: Near-complete (90-99%) reperfusion, or filling of all distal branches with slower flow; mTICI 3: Complete antegrade reperfusion of all branches | End of procedure |
| Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment | Embolization to New Territory (ENT), defined as the presence of new occlusions on final angiography that occur in vascular territories remote from those effected by index stroke, as assessed by the investigator | End of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve mTICI≥2c, defined as groin puncture to investigator assessment for mTICI≥2c | The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2c using study device and technique. mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion. mTICI 0: No antegrade reperfusion; mTICI 1: Antegrade reperfusion past initial occlusion, limited distal filling; mTICI 2a: Antegrade reperfusion of less than half (<50%) of the previously occluded target artery's ischemic territory; mTICI 2b: Antegrade reperfusion of more than half (≥50%) of the previously occluded target artery's ischemic territory; mTICI 2c: Near-complete (90-99%) reperfusion, or filling of all distal branches with slower flow; mTICI 3: Complete antegrade reperfusion of all branches |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects with acute ischemic stroke secondary to large vessel occlusion (LVO) meeting the study eligibility criteria and providing written informed consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pojai Phattanagosai | Contact | 650-740-7703 | pphattanagosai@Imperativecare.com | |
| Emma Pham | Contact | 408-421-7684 | epham@imperativecare.com |
| Name | Affiliation | Role |
|---|---|---|
| David Fiorella, MD | Stony Brook University Hospital | Principal Investigator |
| Shahram Majidi, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital | Recruiting | Huntsville | Alabama | 35801 | United States |
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|
| Intraprocedural |
| Proportion of cases with clot ingestion, as evidenced by clot captured within the Zoom POD | Proportion of cases with clot ingestion, as evidenced by clot captured within at least one of the Zoom PODs | Intraprocedural |
| Proportion of cases with clot captured within the Zoom POD connected to the outer aspiration catheter | Proportion of cases with clot ingestion, as evidenced by clot captured within the outer Zoom PODs | Intraprocedural |
| Rate of rescue therapy | Proportion of cases with rescue therapy, defined as unplanned use of another manufacturer's thrombectomy device, angioplasty, or stenting within the target vessel territory to achieve mTICI≥2c. | Intraprocedural |
| Rate of functional independence (mRS 0-2) at 90 days | Proportion of patients achieving mRS (modified Rankin Scale) ≤2 at 90 days mRS range: 0 to 6; The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death; higher score means worse outcome | 90 days post-procedure |
| Proportion of patients achieving First Pass Effect (FPE) mTICI ≥2c as adjudicated by independent core-lab | Proportion of cases achieving First Pass Effect (FPE), defined as mTICI ≥2c after the first pass with the study device and technique as adjudicated by independent core-lab mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion. mTICI 0: No antegrade reperfusion; mTICI 1: Antegrade reperfusion past initial occlusion, limited distal filling; mTICI 2a: Antegrade reperfusion of less than half (<50%) of the previously occluded target artery's ischemic territory; mTICI 2b: Antegrade reperfusion of more than half (≥50%) of the previously occluded target artery's ischemic territory; mTICI 2c: Near-complete (90-99%) reperfusion, or filling of all distal branches with slower flow; mTICI 3: Complete antegrade reperfusion of all branches | Intraprocedural |
| Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging and independently adjudicated by medical monitor, at the 24-hour post-procedure | Independently adjudicated rate of symptomatic intracranial hemorrhage (sICH) defined as any apparently extravascular blood in the brain or within the cranium confirmed by imaging that is associated with clinical deterioration as defined by an increase of four or more points in the NIHSS at 24 hours compared to the baseline assessment, or that led to death, and was judged to be the predominant cause of a neurologic deterioration or death, per ECASS III criteria | 24-hour post-procedure |
| 90-day all-cause mortality | Rate of all-cause mortality through 90 days post-procedure | 90 days post-procedure |
| Rate of device-related Serious Adverse Events, independently adjudicated medical monitor | Independently adjudicated rate of Serious Adverse Events related to study device | Intraprocedural |
| Justin Masciteli, MD |
| The University of Texas Health Science Center at San Antonio |
| Principal Investigator |
| Maxim Mokin, MD | University of South Florida | Principal Investigator |
| John Muir Health | Recruiting | Walnut Creek | California | 94598 | United States |
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| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
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| Ochsner Clinic Foundation | Not yet recruiting | New Orleans | Louisiana | 70121 | United States |
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| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Allina Health | Recruiting | Minneapolis | Minnesota | 55407 | United States |
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| Albany Medical College | Recruiting | Albany | New York | 12208 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Montefiore Medical Center | Not yet recruiting | The Bronx | New York | 10467 | United States |
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| University of Oklahoma, Health Science Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Prisma Health - Upstate | Recruiting | Greenville | South Carolina | 29605 | United States |
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| Semmes Murphey Foundation | Recruiting | Memphis | Tennessee | 38120 | United States |
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| HCA Houston Healthcare Kingwood | Recruiting | Kingwood | Texas | 77339 | United States |
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| Methodist Healthcare System of San Antonio | Not yet recruiting | San Antonio | Texas | 78229 | United States |
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| University of Texas Science Health Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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| Inova Fairfax Medical Campus | Not yet recruiting | Falls Church | Virginia | 22042 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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