RANDOMIZED (1:1) CONTROLLED Trial
the lower dose Paclitaxel RANGER DCB (2 μg/mm2)
to the higher dose Paclitaxel IN.PACT DCB (3.5 μg/mm2)*
OBJECTIVE: To compare two different Paclitaxel coated balloons
(with different coatings and different paclitaxel dose density) in the treatment of high
grade stenotic or occluded lesions in SFA and/or PPA in PAD patients with Rutherford class 2-4*
*COMPARE-Pilot RCT: 2-year results of a randomized comparison of RANGER DCB vs. IN.PACT DCB in complex SFA lesions released at LINC 2019 by Prof. Dierk Scheinert, MD
Results from the pilot phase, 150 patients. Overall trial will enroll up to 414 patients.
- Prospective, multi-center, randomized trial
- Randomization 1:1
- Phase 1: Pilot study (150 patients)
- Phase 2: Extension (414 patients) for testing of a formal non-inferiority hypothesis
- Follow-up clinical visits at 6, 12 and 24 months
KEY ENROLLMENT CRITERIA:
- Rutherford 2,3 or 4
- Stenotic, restenotic or occlusive lesions (≥ 70% stenosis) in the native non-stented SFA/PPA
- No prior treatment with drug coated balloons or drug-eluting stents in the treated limb
- Lesion ≤ 300 mm, RVD ≥ 4 mm and ≤ 6.5 mm
Patency - Core lab adjudicated (12 months):
Efficacy: patency rate after one year defined as absence of clinically driven Target Lesion Revascularization (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure) or restenosis with Peak Velocity Ratio > 2.4 evaluated by Duplex Ultrasound
TWO YEAR RESULTS:
The new generation Ranger DCB demonstrated similar Patency and Freedom from TLR with significantly less drug compared to the higher dose IN.PACT DCB.
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