TWIN2WIN (Double Stent (DS-EVT) Versus Primary Thrombectomy With One Stent (SS-EVT))

NCT05632458 | Unknown

• 1 other identifier: PR(AG)652/2021
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The use of a double stent retriever (Dual-SR) has been proposed as a safe and effective technique. The invesigators hypothesized that the use of Dual-SR primary could lead to higher first-pass effect rates and better outcomes compared to Single-SR primary. Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving TVS. A randomized study to compare the efficacy of double primary SR versus single primary SR

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Complete recanalization on first pass

  Comparison of the complete recanalization rate in the first pass in the double stent group compared to the simple stent group, defined as TiCI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale)

  4 months

Secondary Outcomes (5)

• Intracerebral hemorrhage

  4 months

• Neurological impairment

  4 months

• Embolization in new territories

  4 months

• Mortality

  4 months

• Infarct in new territory

  4 months

Other Outcomes (4)

• Reperfusion

  4 months

• Procedure time

  4 months

• National Institutes of Health Stroke Scale (NIHSS) at 24h

  4 months

Study Arms (2)

double stent retriever

EXPERIMENTAL

Device: Thrombectomy

single stent retriever

ACTIVE COMPARATOR

Device: Thrombectomy

Interventions

Thrombectomy DEVICE

Thrombectomy using double stent retriever vs thrombectomy using single stent retriever.

double stent retriever; single stent retriever

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinic
• Age ≥18 and ≤85 years. Informed consent obtained from the patient or an acceptable surrogate for the patient (ie, next of kin or legal representative).
• A new disabling focal neurological deficit compatible with acute cerebral ischemia.
• Baseline NIHSS obtained before the procedure, ≥ 6 points. Preictal mRS score of 0 or 2. Treatable as soon as possible and at least within 24 hours of symptom onset, defined as the time the patient was last seen well (at baseline).
• Patients for whom IV t-PA is indicated and who are available for treatment are treated with IV t-PA. For those patients for whom IV t-PA is indicated and available for treatment, IV t-PA should be administered as recommended in the AHA/ASA Guidelines for the Early Management of Patients with Acute Ischemic Stroke ( AIS).
• Neuroimaging
• Occlusion (flow TICI 0 or TICI 1), of the terminal internal carotid artery, segments or distal M1 of the basilar or middle cerebral artery, suitable for mechanical embolectomy, confirmed by conventional angiography.
• The patient is indicated for neurothrombectomy treatment by the Interventionist.
• Participating NRIs will have to complete a teaching module on the DS-EVT

You may not qualify if:

• Clinic
• Functional disability prior to stroke on the modified Rankin scale (mRS \>2). Initial treatment with a different thrombectomy device. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Known bleeding diathesis, coagulation factor deficiency, or known oral anticoagulant therapy with INR \> 3.0.
• Baseline platelet count \< 50,000. Serious, advanced or terminal illness with an expected life expectancy of less than six months.
• Subjects with identifiable intracranial tumors. Brain vasculitis. Evidence of active systemic infection. Known current use of cocaine at the time of treatment. Woman of childbearing age who is known to be pregnant, and/or breastfeeding, or who has a positive pregnancy test at the time of admission.
• Patient participating in a study involving an investigational drug or device that may affect this study.
• Patients who are unlikely to be available for a 90-day follow-up (eg, homeless, visitor from abroad).
• Neurological imaging
• Hypodensity on CT or diffusion-restricted resulting in an ASPECTS score of \< 6 on CT or \< 5 on DMR (diffusion-weighted MRI).
• Evidence of hemorrhage on CT or MRI (the presence of microbleeds is allowed). Angiographic evidence of carotid artery dissection, high-grade stenosis impeding access to the clot, or vasculitis.
• Significant mass effect with midline shift. Patients with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
• Patients with occlusions in multiple vascular territories (for example, bilateral anterior circulation or anterior/posterior circulation).
• Evidence of intracranial tumor (except small meningiomas). Suspected aortic dissection, suspected septic embolus, or suspected bacterial endocarditis.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitario Vall d'Hebrón

Barcelona, 08035, Spain

RECRUITING

Related Publications (1)

• Tomasello A, Moreu M, Terceno M, Dinia L, Barrena Caballo MR, Requena M, Jablonska M, Cendrero J, Flores A, Ortega-Gutierrez S, Diana F, Henandez D, de Dios M, Rubiera M, Garcia-Tornel A, Rizzo F, Olive M, Perez-Garcia C, Trejo Gallego C, Carmona T, Rodrigo-Gisbert M, Molina C, Ribo M. Randomized Study Comparing First-Line Dual Versus Single-Stent Retriever Technique: TWIN2WIN. Stroke. 2025 Feb;56(2):326-334. doi: 10.1161/STROKEAHA.124.048496. Epub 2024 Dec 20.

  PMID: 39704055 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Marc Ribó, Medicine

CONTACT

93489300; marcriboj@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 30, 2022
• Study Start: April 21, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)