Jetstream™

Atherectomy System

 

One-Year Outcome of Percutaneous Rotational Atherectomy With Aspiration in Infrainguinal Peripheral Arterial Occlusive Disease:

The Multicenter Pathway PVD Trial1


Objective

To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions.

Study Design

172 patients with the following inclusion criteria:

  • Documented symptomatic atherosclerotic peripheral vascular disease
  • Target lesion(s) in a superficial femoral, popliteal, and/or infrapopliteal artery
  • Reference vessel lumen proximal to target lesion >3.0 and <5.0 mm in diameter by visual estimation
  • Stenosis >70% and crossable with a guidewire
  • Single or multiple focal stenosis up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the tibial or peroneal arteries

Study Device

Jetstream Atherectomy System (formerly Pathway PV Atherectomy System) 

Lesion Characteristics

Lesion Location  
    SFA ​ 134/210 (64%)​
    Popliteal artery ​ 58/210 (28%)​
    Tibial artery 18/210 (9%)​
Lesion length, mm ​ 27.4±23.9 (3.0–100.0) 95% CI 24.2 to 30.7​
    SFA (n=134) ​ 29.9±26.2 (5.0–100.0) 95% CI 25.4 to 34.4​
    Anterior tibial (n=2) ​ 22.5±10.6 (15.0–30.0) 95% CI 272.8 to 117.8​
    TPT (n=13) ​ 13.9±8.9 (3.0–30.0) 95% CI 8.5 to 19.3​
    Posterior tibial (n=1) ​ 15.0​
    Popliteal (n=57*) ​ 25.8±19.8 (3.0–100.0) 95% CI 20.5 to 31.0​
    Peroneal (n=2) ​ 10.0±0.0 (10.0–10.0)​
Moderate to high calcium ​ 108/210 (51%)​
Total occlusions ​ 64/208 (31%)​
Reference vessel diameter, mm ​ 4.5±0.6 (3.0–6.0) 95% CI 4.4 to 4.6​
    SFA (n=134) ​ 4.6±0.5 (3.5–5.5) 95% CI 4.6 to 4.7​
    Anterior tibial (n=2) ​ 3.0±0.0 (3.0–3.0)​
    TPT (n=13) ​ 3.7±0.8 (3.0–5.0) 95% CI 3.2 to 4.2​
    Posterior tibial (n=1) ​ 3.0​
    Popliteal (n=58) ​ 4.5±0.6 (3.5–6.0) 95% CI 4.3 to 4.6​
    Peroneal (n=2) ​ 3.0±0.0 (3.0–3.0)
* One lesion missing.

Endpoints

  • Primary safety endpoint: freedom from major adverse events (MAE) including clinically driven target lesion revascularization (TLR), any death, target vessel revascularization (TVR), myocardial infarction (MI), and index limb amputation at 30 days post procedure
  • Primary efficacy endpoint: reduction in mean percent stenosis with and without adjunctive therapy

 

Key Clinical Results​

  • Device success was 99% (208/210 lesions)
  • MAE at 30 days was 1% (2 preplanned amputations)
  • Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively
  • The ankle-brachial index increased significantly from 0.59±0.21 at baseline to 0.82±0.27 (p<0.05) at 12 months
  • Mean Rutherford class improved from 3.0±0.9 at baseline to 1.5±1.3 at 1 year (p<0.05)

Total occlusion of a right superficial femoral artery at (A) baseline, (B) after atherectomy, (C) after adjunctive 5-mm balloon angioplasty, and (D) 30 months post procedure. ​

 

Conclusion

This rotational atherectomy device with aspiration capabilities is safe and effective for treating obstructive lesions with a maximum lesion length of 10 cm in infrainguinal arteries with a reference vessel diameter ranging from 3 to 5 mm. 
1.  Zeller T et al. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: themulticenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62.
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