Reperfusion Completion Via Local Arterial Infusion of Tenecteplase After Incomplete Mechanical Thrombectomy

NCT07471282 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: RECLAIM-TNK-2026
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of intra-arterial TNK bridging therapy following incomplete recanalization (2b ≤ eTICI \< 3) after mechanical thrombectomy for acute anterior circulation large vessel occlusion.

Conditions

Stroke

Keywords

Ischemic Stroke with Large Vessel Occlusion; Tenecteplase; Incomplete Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days

  Excellent neurological outcome rate (mRS 0-1) at 90 (±7) days

  3 months after randomization

Secondary Outcomes (8)

• Change in eTICI grade on cerebral angiography

  Immediately after intra-arterial thrombolysis

• Proportion of patients with mRS score 0-2 at 90 (±7) days

  3 months after randomization

• Proportion of patients with mRS score 0-3 at 90 (±7) days

  3 months after randomization

• mRS shift analysis at 90 (±7) days

  3 months after randomization

• Proportion of patients with NIHSS score 0-1 or a decrease from baseline of ≥10 points at 48 (±12) hours

  48 hours after randomization

Other Outcomes (6)

• Incidence of symptomatic intracranial hemorrhage within 48 hours (Heidelberg criteria)

  48 hours after randomization

• Proportion of patients with an increase from baseline of ≥4 points in NIHSS score at 72 (±12) hours

  72 hours after randomization

• Mortality rate at 90 (±7) days

  3 months after randomization

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Intra-arterial thrombolysis using placebo

Drug: Placebo

Tenecteplase Group

EXPERIMENTAL

Intra-arterial thrombolysis using tenecteplase

Drug: Tenecteplase (0.0938mg/kg)

Interventions

Tenecteplase (0.0938mg/kg) DRUG

Post-mechanical thrombectomy bridging therapy with intra-arterial tenecteplase (0.0938 mg/kg) for incomplete recanalization (2b ≤ eTICI \< 3).

Tenecteplase Group

Placebo DRUG

Post-mechanical thrombectomy bridging "therapy" with intra-arterial placebo (0.0938 mg/kg) for incomplete recanalization (2b ≤ eTICI \< 3).

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years;
• Time from symptom onset or last known well to randomization within 24 hours;
• Clinical diagnosis of acute ischemic stroke caused by acute occlusion of the intracranial anterior circulation large vessels confirmed by CTA/MRA/DSA, including occlusion of the intracranial segment of the internal carotid artery, the M1 or M2 segments of the middle cerebral artery, with or without concomitant occlusion of the ipsilateral extracranial segment of the internal carotid artery;
• NIHSS score ≥ 6, and meeting the current guidelines for mechanical thrombectomy;
• Anterior circulation large vessel stroke due to occlusion of the intracranial ICA, MCA M1, or M2 segments;
• Pre-stroke mRS score ≤ 1;
• ASPECTS score ≥ 6;
• Post-mechanical thrombectomy status with 2b ≤ eTICI \< 3, and the operator has decided not to attempt further mechanical recanalization of the occluded vessel;
• No more than 3 passes with the thrombectomy device;
• Signed informed consent obtained from the patient or their legal guardian.

You may not qualify if:

• Contraindications to intravenous thrombolysis (excluding time-based criteria);
• DSA post-thrombectomy indicating dissection of the occluded artery, or intra-procedural flat-panel CT suggesting local hemorrhage or significant contrast extravasation;
• Baseline NIHSS score not obtained;
• Severe allergy or absolute contraindication to iodinated contrast media;
• Systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg, refractory to antihypertensive medication;
• Blood glucose \< 50 mg/dL (2.8 mmol/L) or \> 400 mg/dL (22.2 mmol/L);
• Platelet count \< 50 × 10⁹/L, or APTT \> 40 s, or PT \> 15 s;
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or current use of oral anticoagulants with INR \> 1.7;
• Severe renal failure, defined as serum creatinine \> 3.0 mg/dL (or 265.2 μmol/L) or glomerular filtration rate \[GFR\] \< 30 mL/min, or requiring hemodialysis or peritoneal dialysis;
• Patient unlikely to complete the 90-day follow-up (e.g., no fixed address, palliative care patient, etc.);
• Suspected vasculitis or septic embolism;
• Suspected aortic dissection;
• Pre-existing neurological or psychiatric disease that would interfere with the assessment of outcomes;
• Pregnancy or lactation;
• Current participation in another clinical trial that could interfere with this study;

Sponsors & Collaborators

• Chuansheng Zhao: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Haoyue Zhu

CONTACT

+86-15940220919; zhuhaoyuejason@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Neurology Department

Model Details: Multicenter, randomized, double-blind, placebo-controlled, 1:1 allocation, 90-day follow-up.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CN (1)