DISTALS
(2026)Objective
To evaluate the safety and efficacy of thrombectomy with the Tigertriever 13 stent retriever plus medical management versus medical management alone in MeVO/DVO stroke patients ineligible for IVT, using a tissue-based reperfusion endpoint.
Study Summary
• No sICH occurred in Tigertriever 13–treated patients (the single thrombectomy-arm sICH was in a patient erroneously treated with the larger Tigertriever 17).
• 90-day mRS and quality-of-life outcomes are pending; this report reflects 24-hour imaging-based primary endpoint only.
Intervention
Thrombectomy with Tigertriever 13 stent retriever + medical management vs. medical management alone
Inclusion Criteria
MeVO/DVO stroke (M2 co/non-dominant, M3, A1–A3, P1–P3), NIHSS 4–24 (or 2–24 with aphasia/hemianopia), ineligible for IVT, within 24 hours of last known well
Study Design
Arms: Tigertriever 13 thrombectomy + medical management vs. medical management alone
Patients per Arm: 98 randomized (Thrombectomy: 51, Medical management: 47); 149 enrolled total
Outcome
• Safety: 0% sICH in Tigertriever 13 patients.
• 90-day mRS and QoL outcomes pending.
Bottom Line
Tigertriever 13 thrombectomy achieved dramatically higher rates of successful reperfusion without sICH at 24 hours compared to medical management (86.3% vs 27.7%) in MeVO/DVO stroke patients not eligible for IVT, with no device-related sICH. Clinical 90-day outcomes are pending.
Major Points
- Primary endpoint met: successful reperfusion without sICH at 24 hours was 86.3% with Tigertriever 13 vs 27.7% with medical management (P<0.001).
- 0% sICH in patients treated with Tigertriever 13; the single sICH in the thrombectomy arm occurred in a patient erroneously treated with the larger Tigertriever 17 device.
- Trial enrolled exclusively MeVO/DVO patients ineligible for IVT — a distinctive population.
- Primary endpoint was imaging-based (>50% reduction in substantial hypoperfusion volume at 24h without sICH), not a 90-day clinical outcome.
- Onset-to-randomization time exceeded 7 hours for both arms — substantially longer than DISTAL, ESCAPE-MeVO, and DISCOUNT.
- Higher rate of PCA occlusions compared to prior MeVO RCTs, with similar M2 rates.
- Patient population was younger on average than prior MeVO trials.
- No IVT or anticoagulant therapies were administered in enrolled patients.
- Tigertriever 13 is designed specifically for distal/MeVO anatomy with low delivery profile, imaging visibility, and adjustable force reduction during retrieval.
- 149 patients enrolled total, 118 randomized (51 thrombectomy, 47 medical management); discrepancy between enrollment and randomization not fully detailed.
- Industry-sponsored trial (Rapid Medical); FDA IDE for Tigertriever 13 granted in 2021.
- 90-day mRS and quality-of-life data forthcoming; Rapid Medical plans to pursue full FDA clearance.
Study Design
- Study Type
- Prospective, industry-sponsored, randomized controlled trial (IDE study)
- Randomization
- Yes
- Blinding
- Open-label
- Sample Size
- 118
- Follow-up
- 24 hours (primary endpoint); 90 days (pending)
- Countries
- USA, Germany, Belgium, Sweden
Primary Outcome
Definition: Successful reperfusion defined as >50% reduction in substantial hypoperfusion volume between baseline and 24 hours post-randomization without symptomatic ICH
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 27.7% | 86.3% | - | P<0.001 |
Limitations & Criticisms
- Primary endpoint is imaging-based (24-hour reperfusion), not a 90-day clinical outcome — clinical benefit remains unproven until mRS data are available.
- Very small sample size (51 vs 47 randomized) limits power for safety and subgroup analyses.
- Open-label design with no blinding.
- Industry-sponsored by Rapid Medical, the manufacturer of Tigertriever 13.
- Exclusively enrolled patients ineligible for IVT, limiting generalizability to the broader MeVO population.
- 149 enrolled but only 118 randomized — reasons for the discrepancy not fully detailed in the presentation.
- No 90-day mRS or quality-of-life data yet available.
- Device-specific trial (Tigertriever 13 only) — results may not generalize to other thrombectomy devices/techniques.
- Onset-to-randomization >7 hours in both arms is substantially longer than prior MeVO RCTs, making the population distinct.
- Baseline characteristics limited (conference presentation only; full manuscript pending).
- Single sICH case attributed to protocol deviation (wrong device) — may understate true device-class risk.
Citation
Presented at International Stroke Conference (ISC) 2026