← Back
NeuroTrials.ai
Neurology Clinical Trial Database

Venous-TD

Efficacy and Safety of a Dedicated Device for Cerebral Venous Thrombectomy: A Pilot Randomized Clinical Trial

Share Share Copied! Compare

Year of Publication: 2025

Authors: Yi Xu, MD; Yan Wu, MD; Miaowen Jiang, ..., PhD; Xunming Ji

Journal: Stroke

Citation: Stroke. 2025:56:5-13. DOI: 10.1161/STROKEAHA.124.045607

Link: https://www.ahajournals.org/doi/10.1161/STROKEAHA.124.045607

PDF: https://www.ahajournals.org/doi/epub/10....EAHA.124.045607

Clinical Question

To demonstrate the safety and efficacy of a novel NiTi-braided stent retriever (Venous-TD) for cerebral venous thrombectomy compared to Angioguard with Sterling balloon.

Bottom Line

This pilot randomized trial indicates that Venous-TD significantly increased the proportion of immediate and long-term complete recanalization and reduced severe residual headache at 180 days in cerebral venous thrombosis (CVT) patients undergoing endovascular treatment (EVT), without increasing complications, warranting a multicenter phase III trial.

Major Points

  • A total of 61 patients with cerebral venous thrombosis were enrolled and randomized (31 to Venous-TD, 30 to control group: Angioguard with Sterling balloon).
  • During EVT, Venous-TD significantly improved the proportion of immediate complete recanalization compared with Angioguard (23 [76.7%] vs 6 [20.0%]; relative risk [RR], 3.833 [95% CI, 1.825-8.054]).
  • The operation duration in the Venous-TD group was significantly shorter (median, 30 min vs 151 min; P<0.001).
  • Venous-TD significantly improved the proportion of long-term complete recanalization at 180 days (26 [83.9%] vs 10 [33.3%]; RR, 2.516 [95% CI, 1.482-4.271]).
  • The proportion of patients with severe residual headache at 180 days in the Venous-TD group was significantly lower (3 [9.7%] vs 10 [35.7%]; RR, 0.271 [95% CI, 0.083-0.886]).
  • The proportions of long-term functional independence at 180 days were not significantly different between the two groups (27 [87.1%] vs 24 [80.0%]; RR, 1.089 [95% CI, 0.870-1.363]).
  • Safety outcomes (peri-procedural complications, all-cause mortality, and symptomatic intracranial hemorrhage) showed no statistically significant difference between the two groups.
  • No patients died during EVT or within 180 days in the Venous-TD group; 2 patients died in the control group within 90 days.

Design

Study Type: Pilot, prospective, randomized, single-blind, parallel-group control, single-center clinical study

Randomization: 1

Blinding: Single-blind (assessors of functional outcomes were blinded to treatment randomization). Patients and surgeons were not blinded.

Enrollment Period: March 2022 to January 2023

Follow-up Duration: 180 days

Centers: 1

Countries:

Sample Size: 61

Analysis: Intention-to-treat approach for comparisons between 2 groups. Quantitative indicators expressed as relative risk ratios with 95% CIs. Chi-square test or Fisher exact test for classification indicators, Wilcoxon rank-sum test for rank data. Univariate and multivariate logistic regression analyses for odds ratios and 95% CIs to identify risk factors for severe headache. SPSS 22.0 and R 4.3.0 used for data analysis.

Inclusion Criteria

  • Adults aged 18 to 85 years.
  • Intracranial venous sinus thrombosis in acute or subacute stage (≤28 days from onset to diagnosis) confirmed by clinical and imaging examination.
  • Meeting the indications for EVT.

Exclusion Criteria

  • Isolated cortical venous thrombosis without venous sinus thrombosis or isolated cavernous sinus thrombosis.
  • Recurrent intracranial venous sinus thrombosis.
  • Pregnancy.
  • Contraindications of anticoagulation or thrombolysis.

Baseline Characteristics

CharacteristicControlActive
Age, y; median (IQR)34 (24-43)28 (21-45)
Sex (male), n (%)13 (43.3)16 (51.6)
BMI, kg/m²; median (IQR)24.15 (22.37-27.58)24.61 (23.15-27.64)
Onset-treatment-, d; median (IQR)9 (5-24)16 (9-24)
Clinical manifestations - NIHSS score >8, n (%)11 (36.7)8 (25.8)
Clinical manifestations - GCS, median (IQR)15 (11-15)15 (13-15)
Clinical manifestations - Moderate to severe headache, n (%)23 (76.7)27 (87.1)
Clinical manifestations - Tinnitus, n (%)5 (16.7)2 (6.5)
Clinical manifestations - Nausea and vomiting, n (%)15 (50.0)17 (54.8)
Clinical manifestations - Epilepsy, n (%)11 (36.7)10 (32.3)
Clinical manifestations - Focal neurofunctional deficiency, n (%)12 (40.0)6 (19.4)
Clinical manifestations - Blurred vision, n (%)7 (23.3)10 (32.3)
Imaging manifestations - ≥3 venous, n (%)19 (63.3)27 (87.1)
Imaging manifestations - Transverse sinus, n (%)21 (70.0)28 (90.3)
Imaging manifestations - Straight sinuses, n (%)5 (16.7)9 (29.0)
Imaging manifestations - Superior sagittal sinus, n (%)21 (70.0)25 (80.6)
Imaging manifestations - Sigmoid sinus, n (%)22 (73.3)27 (87.1)
Imaging manifestations - Cortical veins, n (%)10 (33.3)4 (12.9)
Imaging manifestations - Internal jugular veins, n (%)12 (40.0)9 (29.0)
Imaging manifestations - Venous infarction, n (%)15 (50.0)19 (61.3)
Imaging manifestations - Parenchymal hemorrhage, n (%)13 (43.3)8 (25.8)
Imaging manifestations - Subarachnoid hemorrhage, n (%)7 (23.3)2 (6.5)
Red blood cell count (10^12/L), median (IQR)4.55 (4.11-4.90)4.65 (4.29-5.18)
White blood cell count (10^9/L), median (IQR)7.61 (5.76-11.36)8.03 (6.86-9.58)
Platelet count (10^9/L), median (IQR)187 (144-250)233 (200-289)
Blood homocysteine >20 µmol/L, n (%)7 (23.3)9 (29.0)
D-dimer >0.5 µg/mL, n (%)21 (70.0)25 (80.6)
Intracranial pressure >180 mmH2O, n (%)28 (93.3)28 (90.3)
Duration of hospital admission, d; median (IQR)16 (11-22)16 (14-23)
Local thrombolysis, n (%)16 (53.3)17 (54.8)
ICT before thrombectomy (≤20 s), s; median (IQR)16 (13.5-18; in 27)16 (14.25-16.75; in 28)
ICT before thrombectomy >20 s, n (%)3 (10.0)2 (6.7; in 30)

Arms

FieldVenous-TD groupControl
InterventionEndovascular thrombectomy (EVT) with Venous-TD (a newly developed NiTi-braided stent retriever designed specifically for removing blood clots from the venous sinus). Procedures performed under general anesthesia, with systematic heparinization, collection and retransfusion of salvaged blood, and local thrombolysis by urokinase (at surgeon's discretion).Endovascular thrombectomy (EVT) with Angioguard (6 mm, Cordis) and a Sterling balloon dilatation catheter (Boston Scientific Corporation). Procedures performed under general anesthesia, with systematic heparinization, collection and retransfusion of salvaged blood, and local thrombolysis by urokinase (at surgeon's discretion).
DurationAcute procedure (followed by 180-day follow-up)Acute procedure (followed by 180-day follow-up)

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Proportion of immediate complete recanalization during EVT. Complete recanalization was defined as blood flow without any interruption.Primary6 (20.0%)23 (76.7%)3.833
Immediate recanalization (complete and partial)Secondary27 (90.0%)30 (100%)
Operation duration (min)Secondary151 (IQR, 127-190)30 (IQR, 25-35)<0.001
ICT right after thrombectomy (s)Secondary13 (IQR, 12.5-16)13 (IQR, 12-14)0.084
ΔICT (ICT before thrombectomy - ICT right after thrombectomy) (s)Secondary1 (IQR, 1-2)2 (IQR, 2-3)0.045
Intracranial pressure >180 mmH2O at 7 d after EVTSecondary13 (43.3%)13 (41.9%)0.968
Functional independence (mRS score of 0-2) at 30 daysSecondary23 (76.7%)26 (83.9%)1.094
Functional independence (mRS score of 0-2) at 90 daysSecondary24 (80.0%)27 (87.1%)1.089
Functional independence (mRS score of 0-2) at 180 daysSecondary24 (80.0%)27 (87.1%)1.089
Recurrence of CVT in 180 daysSecondary1 (3.3%)1 (3.2%)0.968
Long-term complete recanalization (at 180 days)Secondary10 (33.3%)26 (83.9%)2.516
Moderate to severe residential headache at 30 daysSecondary14 (48.3%; in 29)9 (29.0%)0.601
Moderate to severe residential headache at 90 daysSecondary11 (37.9%; in 29)5 (16.1%)0.628
Moderate to severe residential headache at 180 daysSecondary10 (35.7%; in 28)3 (9.7%)0.271

Criticisms

  • This is a pilot trial performed in a single center, which leads to inevitable bias and limits generalizability. A multicenter study is ongoing to address this.
  • The control group used Angioguard with Sterling balloon, which is an arterial thrombectomy device used off-label for venous thrombectomy. This limits the comparability to standard medical care (full-dose anticoagulation) and warrants a control group treated by anticoagulation only in future studies.
  • The primary outcome was recanalization, an anatomic outcome, rather than a functional outcome. A future study setting functional outcome as the primary outcome is needed.
  • The small sample size (n=61) leads to important imbalances between the two treatment arms in baseline characteristics including age, onset-to-treatment time, focal deficits, ICH, etc.
  • The site of the thrombus was slightly different between the two groups, which may have influenced the results.
  • For outcomes during the operation, the assessors were the surgeons who were not blinded to the device, which is a main limitation of the trial and a source of potential bias.
  • Early reocclusion after EVT, an important issue in CVT, was not investigated by early control venography.

Subgroup Analysis

No subgroup analyses were performed. The study is a pilot trial with a small sample size.

Funding

National Natural Science Foundation of China (82027802, 82102220, 82271507, 82171278, 82271311, and 82171304), Capital's Funds for Health Improvement and Research (No. 2024-2-2017), and Collaborative Technology Innovation Research from Medicine Beijing Municipal Commission of Science and Technology (Z181100001918026).

Based on: Venous-TD (Stroke, 2025)

Authors: Yi Xu, MD; Yan Wu, MD; Miaowen Jiang, ..., PhD; Xunming Ji

Citation: Stroke. 2025:56:5-13. DOI: 10.1161/STROKEAHA.124.045607

Content summarized and formatted by NeuroTrials.ai.