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 both 24-hour tissue-based reperfusion and 90-day clinical endpoints.
Study Summary
• sICH 0% vs 0%; asICH 20% vs 3.5% (P=0.01).
• 90-day mRS 0–1: 41% vs 38% (NS); mortality 7.4% vs 7.0% (NS).
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; vessel diameter ≥1.5 mm), NIHSS 4-24 (or 2-24 with aphasia/hemianopia), ineligible for IVT, within 24h of last known well, target mismatch on perfusion imaging (Tmax >4s lesion ≥10 mL, mismatch ratio ≥2). USA and EU sites; FDA-approved IDE study.
Study Design
Arms: Tigertriever 13 thrombectomy + medical management vs. medical management alone
Patients per Arm: Thrombectomy n=61 vs Medical management n=57
Outcome
• Safety: sICH 0% vs 0%; asICH 20% vs 3.5%, P=0.01.
• 90-day mortality: 7.4% vs 7.0% (NS).
• 90-day mRS 0-1: 41% vs 38% (NS).
Bottom Line
In MeVO/DVO stroke patients ineligible for IVT, Tigertriever 13 thrombectomy produced dramatically higher 24-hour reperfusion than medical management (86.3% vs 27.7%, P<0.0001) with 0% symptomatic ICH in both arms. However, asymptomatic ICH was higher with thrombectomy (20% vs 3.5%, P=0.01), and 90-day clinical outcomes (mortality 7.4% vs 7.0%; mRS 0-1 41% vs 38%) did not differ significantly. The device is safe and technically effective, but a clinical benefit at 90 days was not demonstrated.
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<0.0001).
- Symptomatic ICH was 0% in BOTH arms; asymptomatic ICH was significantly higher with thrombectomy (20% vs 3.5%, P=0.01).
- 90-day mortality did not differ between arms (7.4% vs 7.0%, NS).
- 90-day functional independence (mRS 0-1) did not differ (41% vs 38%, NS).
- Trial enrolled exclusively MeVO/DVO patients ineligible for IVT — a distinctive population.
- Primary endpoint was imaging-based (>50% reduction in Tmax >4s hypoperfusion volume at 24h without sICH), not a 90-day clinical outcome.
- Mean age 69 years, median NIHSS 7, M2 occlusion in ~40%; onset-to-randomization ~8 hours, mainly performed under general anesthesia.
- Target mismatch required: Tmax >4s lesion ≥10 mL and mismatch ratio ≥2.
- 118 randomized in total (Tigertriever 13: n=61; Medical management: n=57).
- Tigertriever 13 is designed specifically for distal/MeVO anatomy with low delivery profile, imaging visibility, and adjustable force reduction during retrieval.
- Industry-sponsored trial (Rapid Medical); FDA IDE study.
- Conclusion (per investigators): EVT with Tigertriever 13 is a safe and technically effective treatment strategy for DMVO patients, though clinical superiority at 90 days was not shown.
Study Design
- Study Type
- Prospective, industry-sponsored, randomized controlled trial (FDA-approved IDE study)
- Randomization
- Yes
- Blinding
- Open-label
- Sample Size
- 118
- Follow-up
- 24 hours (primary imaging endpoint); 90 days (clinical outcomes)
- Countries
- USA, EU
Primary Outcome
Definition: Successful reperfusion defined as >50% reduction in Tmax >4s hypoperfusion volume between baseline and 24 ± 6 hours post-randomization, without symptomatic ICH (sICH defined as PH2 or remote ICH causing ≥4-point NIHSS worsening)
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 27.7% | 86.3% | - | P<0.0001 |
Limitations & Criticisms
- Primary endpoint is imaging-based (24-hour reperfusion), not a 90-day clinical outcome; 90-day functional outcomes (mRS 0-1) and mortality were not significantly different, so the clinical benefit of the technical/imaging success was not demonstrated.
- Asymptomatic ICH was significantly higher in the thrombectomy arm (20% vs 3.5%, P=0.01) — long-term implications uncertain.
- Small sample size (n=61 vs n=57) limits power for clinical efficacy 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.
- Device-specific trial (Tigertriever 13 only) — results may not generalize to other thrombectomy devices/techniques.
- Onset-to-randomization ~8 hours is longer than prior MeVO RCTs, making the population distinct.
- Required perfusion-based target mismatch selection, which may not be feasible or available at all centers.