NCT03469206: DIRECT-MT

Direct Intra-arterial Thrombectomy in Order to Revascularize AIS Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals

Completed NA Last updated 29 October 2019

What this trial tests

NA trial testing intra-arterial thrombectomy in Ischemic Stroke in 656 participants. Completed in 26 October 2019.

Timeline

21 February 2018

Primary endpoint
20 October 2019

26 October 2019

Quick facts

Lead sponsor	Changhai Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	656
Start date	21 February 2018
Primary completion	20 October 2019
Estimated completion	26 October 2019
Sites	1 location across China

Drugs / interventions tested

• intra-arterial thrombectomy
• Intravenous thrombolysis — full drug profile →

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →
• Large Vessel Occlusion — all drugs for Large Vessel Occlusion →
• Thrombectomy — all drugs for Thrombectomy →
• Thrombosis — all drugs for Thrombosis →

Sponsor

Changhai Hospital

Who can join

18 and older, any sex, with Ischemic Stroke or Large Vessel Occlusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke.
   Yang P, Zhang Y, Zhang L, Zhang Y, et al · · 2020 · cited 626× · PMID 32374959 · DOI 10.1056/nejmoa2001123
2. Thrombus Migration Paradox in Patients With Acute Ischemic Stroke.
   Alves HC, Treurniet KM, Jansen IGH, Yoo AJ, et al · · 2019 · cited 81× · PMID 31597552 · DOI 10.1161/strokeaha.119.026107
3. Clinical and Imaging Indicators of Hemorrhagic Transformation in Acute Ischemic Stroke After Endovascular Thrombectomy.
   Tian B, Tian X, Shi Z, Peng W, et al · · 2022 · cited 74× · PMID 34872341 · DOI 10.1161/strokeaha.121.035425
4. Endovascular Treatment With or Without Prior Intravenous Alteplase for Acute Ischemic Stroke.
   Chalos V, LeCouffe NE, Uyttenboogaart M, Lingsma HF, et al · · 2019 · cited 49× · PMID 31140355 · DOI 10.1161/jaha.118.011592
5. MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion-study protocol for a randomized clinical trial.
   Treurniet KM, LeCouffe NE, Kappelhof M, Emmer BJ, et al · · 2021 · cited 47× · PMID 33588908 · DOI 10.1186/s13063-021-05063-5
6. Endovascular treatment of acute ischemic stroke due to tandem lesions of the anterior cerebral circulation: a multicentric Italian observational study.
   Bracco S, Zanoni M, Casseri T, Castellano D, et al · · 2021 · cited 34× · PMID 33502665 · DOI 10.1007/s11547-020-01331-7
7. Prognosis and risk factors for reocclusion after mechanical thrombectomy.
   Li W, Ding J, Sui X, Qi Z, et al · · 2020 · cited 31× · PMID 32154677 · DOI 10.1002/acn3.50999
8. Predictors and outcome of early neurological deterioration after endovascular thrombectomy: a secondary analysis of the DIRECT-MT trial.
   Zhang M, Xing P, Tang J, Shi L, et al · · 2023 · cited 29× · PMID 35688618 · DOI 10.1136/neurintsurg-2022-018976