Preliminary results of the multicenter Spanish registry in lower limb ischemia treated with iVascular’s luminor drug eluting balloon

Background

The Paclitaxel-eluting balloonluminor”, in its versions for 0.014″, 0.018″ and 0.035″ guidewires, is a coaxial catheter designed for percutaneous transluminal angioplasties of peripheral arteries (iliac, femoral, popliteal and below-the-knee).

The balloon is coated with an homogeneous mixture of Paclitaxel, a derivative of Taxol, and a  physiologically innocuous matrix as excipient. The drug dose is 3 µg/mm2 and is intended to avoid cellular proliferation (restenosis), consequently decreasing re-intervention rate (TLR – Target Lesion Revascularization).

The coating is applied using iVascular’s proprietary technology “Transfertech” based on a spray dosage system of drug nano-drops. The overall result is a thin multi-layer coating with micro-crystalline structure that enhances drug transfer to the arterial wall.

Luminor Registry is an observational, prospective and multicentre study with single-arm treatment for native stenotic or occlusive lesions or in-stent stenosis of the femoro-poplietal (FP) and below the knee (BTK) vessels. The objective is to evaluate the performance of luminor drug-eluting balloons in terms of primary patency and freedom of serious adverse events. A maximum of 250 Rutherford 2-5 cases will be recruited following an intention to treat basis.

Results

Since Q4 – 2014, 143 cases with 165 lesions (81 CTO and 84 stenosis, 7.2±5.8cm and 5.9±4.5cm long respectively) have been included and monitored. Injury locations were 101 FP, 36 BTK and 14 FP+BTK:

  • 7 of them were in-stent stenosis
  • 82 patients were classified as Rutherford 5 (57.3%)
  • Technical success was achieved in 99.7% of the cases
  • Bailout stenting was necessary in 13 lesions (7.8%)
  • The cumulative primary patency rate at 6 months was 85.3%
  • 96 patients accomplished 6 month follow-up. For them, 30-day-mortality was 1.4%, with 8 major amputations (8.3%) and 6 TLR (6.3%; freedom TLR of 93.7%)

Conclusions

Initial primary endpoints are encouraging, even in patients with highly severe ischemic status (Rutherford 5 in 57.3% of the cases). Interim and final results will be published in future reports.

Data reported by F. Acín (Hospital Universitario de Getafe), M. de Blas (Hospital Universitario de Donostia), M. Alonso (Hospital Universitario Central Asturias), A. Giménez-Gaibar (Hospital Parc Taulí), V. Riambau (Hospital Clínic de Barcelona), representing LUMINOR registry collaborators.

 

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