Venous-TD
Efficacy and Safety of a Dedicated Device for Cerebral Venous Thrombectomy: A Pilot Randomized Clinical Trial
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
PDF: 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
| Characteristic | Control | Active |
|---|---|---|
| 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
| Field | Venous-TD group | Control |
|---|---|---|
| Intervention | Endovascular 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). |
| Duration | Acute procedure (followed by 180-day follow-up) | Acute procedure (followed by 180-day follow-up) |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Proportion of immediate complete recanalization during EVT. Complete recanalization was defined as blood flow without any interruption. | Primary | 6 (20.0%) | 23 (76.7%) | 3.833 | |
| Immediate recanalization (complete and partial) | Secondary | 27 (90.0%) | 30 (100%) | ||
| Operation duration (min) | Secondary | 151 (IQR, 127-190) | 30 (IQR, 25-35) | <0.001 | |
| ICT right after thrombectomy (s) | Secondary | 13 (IQR, 12.5-16) | 13 (IQR, 12-14) | 0.084 | |
| ΔICT (ICT before thrombectomy - ICT right after thrombectomy) (s) | Secondary | 1 (IQR, 1-2) | 2 (IQR, 2-3) | 0.045 | |
| Intracranial pressure >180 mmH2O at 7 d after EVT | Secondary | 13 (43.3%) | 13 (41.9%) | 0.968 | |
| Functional independence (mRS score of 0-2) at 30 days | Secondary | 23 (76.7%) | 26 (83.9%) | 1.094 | |
| Functional independence (mRS score of 0-2) at 90 days | Secondary | 24 (80.0%) | 27 (87.1%) | 1.089 | |
| Functional independence (mRS score of 0-2) at 180 days | Secondary | 24 (80.0%) | 27 (87.1%) | 1.089 | |
| Recurrence of CVT in 180 days | Secondary | 1 (3.3%) | 1 (3.2%) | 0.968 | |
| Long-term complete recanalization (at 180 days) | Secondary | 10 (33.3%) | 26 (83.9%) | 2.516 | |
| Moderate to severe residential headache at 30 days | Secondary | 14 (48.3%; in 29) | 9 (29.0%) | 0.601 | |
| Moderate to severe residential headache at 90 days | Secondary | 11 (37.9%; in 29) | 5 (16.1%) | 0.628 | |
| Moderate to severe residential headache at 180 days | Secondary | 10 (35.7%; in 28) | 3 (9.7%) | 0.271 | |
| New intracranial hemorrhage (during operation) | Adverse | 2 (6.7%) | 1 (3.3%) | 0.492 | |
| Aggravation of primary intracranial hemorrhage (during operation) | Adverse | 2 (6.7%) | 1 (3.3%) | 0.492 | |
| Puncture point hematoma/pseudoaneurysm (during operation) | Adverse | 3 (10.0%) | 2 (6.7%) | 1 | |
| Mortality at 30 d (after operation) | Adverse | 1 (3.3%) | NA | ||
| Mortality at 90 d (after operation) | Adverse | 1 (3.3%) | NA | ||
| Mortality at 180 d (after operation) | Adverse | 2 (6.7%) | NA | ||
| Symptomatic intracranial hemorrhage in 180 d (after operation) | Adverse | 1 (3.3%) | 1 (3.2%) | 1 |
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
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