Lisbon, September 23rd, 2018. iVascular demonstrates benefits of leading products at CIRSE 20. 18The 12-month results from the full clinical cohort of the EFFPAC randomized controlled trial (RCT), were presented by Prof.Ulf Teichgräber (Jena University, Germany) at CIRSE 2018.
Main objective of EFFPAC RCT was to assess the effectiveness of Luminor drug coated balloon (DCB) vs. Uncoated balloon catheter (POBA), in the superficial femoral and popliteal arteries. The EFFPAC RCT 12-month outcomes are all demonstrating high statistical significance versus POBA and beyond meeting all endpoints, EFFPAC also highlights that Luminor DCB is the only DCB proving statistically significant improvement of patients’ clinical status.
EFFPAC RCT 12 months outcomes:
- Primary endpoint: Late Lumen Loss (LLL) at 6 months: 0.14mm (vs 1.06mm in POBA group, p<0.001).
- Target Lesion Revascularization (TLR) at 12 months: 1.3% (vs 17.7% in POBA group, p<0.001).
- Primary Patency (PP) at 12 months: 90.3% (vs. 65.3% in POBA group, p<0.001).
- Rutherford stage improvement at 12 months: 90.6% Luminor group (p=0.006).
Prof. Ulf Teichgräber, PI of the trial, stated that “EFFPAC astonishing outcomes are the result of the innovative coating technology of Luminor DCB“.