Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Parallel Group, Randomized Clinical Trial of Direct Intra-arterial Thrombectomy Versus Intravenous Thrombolysis With Intra-arterial Thrombectomy for Patients With Large Vessel Occlusion of the Anterior Circulation
Brief Summary: Background: Intravenous thrombolysis (IVT) combined with mechanical thrombectomy (MT) has been proven safe and effective in patients with acute ischemic stroke (AIS) of anterior circulation large vessel occlusion (LVO). Despite recanalization, a considerable proportion of patients do not recover. The incidence of symptomatic intracerebral hemorrhage (sICH) was similar between combined IVT plus MT and IVT, suggesting that this complication could not be attributed to the MT, but rather to pre-treatment with IVT. Meanwhile, the incidence of intracranial atherosclerosis stenosis (ICAS) is higher in Asians. It is not clear whether patients with ICAS benefit from pretreatment with alteplase or not and how ICAS modifies treatment effect.

Objective: To assess whether direct MT is non-inferior compared to combined IVT plus MT in patients with AIS due to an anterior circulation LVO, and to assess treatment effect modification by presence of ICAD.

Study design: This is a parallel group, RCT of direct MT compared to combined IVT plus MT, using a non-inferiority design. The trial has observer blinded assessment of the primary outcome and of neuro-imaging at baseline and follow up. The trial will be executed in collaboration with MRCLEAN NO-IV investigators.

Study population: Patients with AIS of anterior circulation VLO confirmed by CTA. Initiation of IVT must be feasible within 4.5 hours from symptom onset. Age must be 18 or over and NIHSS 2 or more.

Main outcomes: The full distribution of the mRS at 3 months. Secondary outcomes: 1. death within 90 +/- 14 days; 2. pre-interventional reperfusion assessed on first intracranial DSA; 3. eTICI19 score on final angiography of MT; 4. score on the NIHSS at 24 +/- 6 hours and 5-7 days, or at discharge; 5. recanalization rate at 24-72h by CTA; 6. Final lesion volume at 5-7 days on NCCT20; 7. score on the EuroQoL 5-dimensions 5-level (EQ5D-5L)21 and Barthel index22 at 90 +/- 14 days; 8. dichotomous clinical outcome on the mRS at 90 +/- 14 days.


Options:
A: Arm Label: ADAPT; Type: EXPERIMENTAL; Interventions: Procedure: direct aspiration procedure | Arm Label: Stent Retriever; Type: ACTIVE_COMPARATOR; Interventions: Procedure: stent retriever procedure | Intervention Type: PROCEDURE; Name: direct aspiration procedure; Assigned to Arm(s): ADAPT | Intervention Type: PROCEDURE; Name: stent retriever procedure; Assigned to Arm(s): Stent Retriever
B: Arm Label: ADAPT Technique/Standard SR Group; Type: OTHER; Interventions: Other: Adapt/Standard Stent Retriever (SR) Group | Intervention Type: OTHER; Name: Adapt/Standard Stent Retriever (SR) Group; Assigned to Arm(s): ADAPT Technique/Standard SR Group
C: Arm Label: IV t-PA with Solitaire™ revascularization device; Type: EXPERIMENTAL; Interventions: Device: Solitaire revascularization device | Arm Label: IV t-PA; Type: ACTIVE_COMPARATOR; Interventions: Drug: Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) | Intervention Type: DRUG; Name: Intravenous (IV) recombinant human tissue plasminogen activator (rtPA); Assigned to Arm(s): IV t-PA | Intervention Type: DEVICE; Name: Solitaire revascularization device; Assigned to Arm(s): IV t-PA with Solitaire™ revascularization device
D: Arm Label: Direct MT; Type: SHAM_COMPARATOR; Interventions: Procedure: intra-arterial thrombectomy | Arm Label: IVT combine with MT; Type: ACTIVE_COMPARATOR; Interventions: Procedure: intra-arterial thrombectomy, Drug: Intravenous thrombolysis | Intervention Type: PROCEDURE; Name: intra-arterial thrombectomy; Assigned to Arm(s): Direct MT, IVT combine with MT | Intervention Type: DRUG; Name: Intravenous thrombolysis; Assigned to Arm(s): IVT combine with MT

Answer: D