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RapidResearchSeries

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Growing Healthcare Impact: 25+ Clinical Trials Worldwide

See trial details below: including objective, status, design, endpoint, and more.

APRIL

OBJECTIVE

To evaluate if administration of ApTOLL intravenously at different doses is safe and well tolerated compared to placebo when administered with endovascular therapy (EVT)± i.v. rt-PA for treatment of acute ischemic stroke.

Status

Complete

SELECTION
RAPID imaging for 100% of patients
DESIGN
Prospective, randomized, double-blinded
TX WINDOW
0-24 hours
ENDPOINT
90-day mRS

BRIGHT

OBJECTIVE

To determine the safety and efficacy of multiple doses of the LT3001 drug product in Acute Ischemic Stroke (AIS) subjects, who are ineligible for thrombectomy or IV tPA, and who have target mismatch profile of ischemic core volume ≤70 mL, mismatch ratio ≥1.2, and mismatch volume ≥5mL.

STATUS

Ongoing

SELECTION
RAPID imaging for 100% of patients
DESIGN
Placebo-controlled, randomized, double-blinded
TX WINDOW
24 hours
ENDPOINT
90-day mRS after 1st IP administration

CRISP

OBJECTIVE

Determine if Rapid CTP can help physicians accurately predict response to recanalization in AIS patients undergoing endovascular therapy.

STATUS

Patients with a Target mismatch profile on Rapid who were treated up to 18 hours after stroke onset had a favorable clinical response rate of 83% following reperfusion.

SELECTION
Rapid imaging for 100% of patients
DESIGN
Prospective, observational
TX WINDOW
0–18 hours
ENDPOINT
30-day NIHSS

DAWN

OBJECTIVE

Evaluate if Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in selected AIS patients.

STATUS

Early termination for efficacy. Highest rate of clinical benefit (36% absolute risk reduction) in any endovascular stroke trial.

SELECTION
Rapid imaging for 100% of patients
DESIGN
PROBE, adaptive design
TX WINDOW
6–24 hours
ENDPOINT
90-day average weighted mRS

DEFUSE 2

OBJECTIVE

Determine if perfusion imaging can help identify which patients, who are ineligible or failed IV tPA, are most likely to benefit from an endovascular clot removal procedure.

STATUS

Complete

SELECTION
Rapid imaging for 100% of patients
DESIGN
Prospective, observational
TX WINDOW
0–12 hours
ENDPOINT
30-day NIHSS

DEFUSE 3

OBJECTIVE

Assess the safety and efficacy of thrombectomy in carefully selected patients in an extended time window.

STATUS

Stopped for efficacy

SELECTION
Rapid imaging for 100% of patients
DESIGN
PROBE, adaptive design
TX WINDOW
6–16 hours
ENDPOINT
90-day mRS

EXTEND

OBJECTIVE

Determine if AIS patients selected with significant penumbral mismatch (measured by MRI criteria) will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.

STATUS

Stopped for efficacy

SELECTION
Rapid imaging for 100% of patients
DESIGN
Prospective, randomized, double-blinded
TX WINDOW
3–9 hours
ENDPOINT
mRS 0-1 at 90 days

EXTEND-IA

OBJECTIVE

Determine whether more advanced imaging selection, newer generation devices, and earlier intervention improve outcomes.

STATUS

Early termination for efficacy. Highest rate of favorable clinical outcome (71%) in any endovascular stroke trial.

SELECTION
Rapid imaging for 100% of patients
DESIGN
PROBE, adaptive design
TX WINDOW
0–6 hours
ENDPOINT
Reperfusion at 24 hrs; NIHSS reduction ≥ 8 or Day 3 NIHSS 0 or 1

EXTEND-IA-TNK

OBJECTIVE

Assess the efficacy and safety of intravenous tenecteplase vs. tPA for bridging therapy prior to early window thrombectomy.

STATUS

Complete

SELECTION
Rapid imaging
DESIGN
Prospective, randomized, open-label, blinded endpoint (PROBE)
TX WINDOW
0–6 hours
ENDPOINT
Proportion of patients with substantial angiographic reperfusion (as defined by mTICI score of 2b/3) at initial angiogram

EVACUATE

OBJECTIVE

To test the hypothesis that ultra-early minimally invasive haematoma removal in patients with supratentorial ICH within 8 hours of onset will improve functional outcomes compared to standard therapy.

STATUS

Enrolling

SELECTION
RAPID imaging
DESIGN
Prospective, randomized, blinded endpoint
TX WINDOW
0-8 hours
ENDPOINT
6-months mRS

FRAME

OBJECTIVE

Investigate the relationship between the success of mechanical thrombectomy performed within 6 hours after onset, the rate of good functional outcome at 3 months, and the presence or absence of Target mismatch on acute multimodal imaging.

STATUS

Complete

SELECTION
Rapid imaging for 100% of patients
DESIGN
Prospective, observational
TX WINDOW
0–6 hours
ENDPOINT
90-day mRS

FRAME-LP

OBJECTIVE

To evaluate the efficacy of endovascular treatment in addition to best medical treatment versus best medical treatment on functional outcome at 3 months in patients with an anterior LVO (ICA/M1/Tandem) related large infarction (>70 mL) and a substantial mismatch (ratio>1.4) up to 24 hours after onset.

STATUS

Start-Up

SELECTION
RAPID imaging
DESIGN
Multicenter, randomized (1:1), controlled, open-label, in two balanced parallel groups with blinded endpoint evaluation (PROBE design), superiority phase III therapeutic trial.
TX WINDOW
0h - 24h
ENDPOINT
90-day mRS

ImPACT-P

OBJECTIVE

Assess the efficacy of augmenting CBF to preserve the penumbra in AIS patients.

STATUS

Enrolling

SELECTION
Rapid imaging for 100% of patients
DESIGN
Prospective, randomized, double-blind
TX WINDOW
5 days
ENDPOINT
5-day infarct volume

REPERFUSE

OBJECTIVE

Evaluate the efficacy of P2Y12 inhibitor (cangrelor) in addition to MT and BMM compared to MT and BMM alone on favorable functional outcome (i.e. mRS ≤ 2) at 3 months, in AIS patients selected on perfusion imaging between 6h and 24h after stroke onset.

STATUS

Enrolling

SELECTION
RAPID imaging
DESIGN
Prospective, randomized (1:1 ratio), open-label study with blinded evaluation (PROBE design).
TX WINDOW
6h - 24h
ENDPOINT
90-day mRS

RESILIENT

OBJECTIVE

Determine if AIS patients due to LVO, treated with combined IV tPA and Solitaire within 6 hours of symptom onset have less stroke-related disability than those patients treated with IV tPA alone.

STATUS

Complete

SELECTION
Rapid imaging selection
DESIGN
PROBE, sequential design
TX WINDOW
0–6 hours
ENDPOINT
90-day mRS

SELECT

OBJECTIVE

Evaluate different imaging selection methodologies and identify which method provides the highest predictive ability in the selection of AIS patients for IAT.

STATUS

Complete

SELECTION
Rapid imaging for 100% of patients
DESIGN
Prospective, observational
TX WINDOW
0–24 hours
ENDPOINT
90-day mRS

SELECT2

OBJECTIVE

Evaluate the safety and efficacy of endovascular thrombectomy in AIS patients with a large core.

STATUS

Enrolling

SELECTION
Rapid imaging
DESIGN
Prospective, randomized, assessor-blinded controlled trial
TX WINDOW
0–24 hours
ENDPOINT
90-day mRS

SWIFT PRIME

OBJECTIVE

Determine if AIS patients due to LVO, treated with combined IV tPA and Solitaire within 6 hours of symptom onset have less stroke-related disability than those patients treated with IV tPA alone.

STATUS

Early termination for efficacy. Second highest rate of favorable clinical outcome in any endovascular stroke trial.

SELECTION
Rapid imaging for 80% of patients
DESIGN
PROBE, sequential design
TX WINDOW
0–6 hours
ENDPOINT
90-day mRS

TIMELESS

OBJECTIVE

Evaluate the efficacy and safety of Tenecteplase compared with placebo in patients with AIS and evidence of salvageable tissue on their baseline imaging.

STATUS

Enrolling

SELECTION
Rapid imaging
DESIGN
Prospective, randomized, open-label, double-blind
TX WINDOW
4.5–24 hours
ENDPOINT
90-day mRS