Ranger II SFA Pivotal Trial1
12-Month results from the Ranger II SFA Pivotal Trial, a prospective, multi-center, randomized controlled trial
(3:1 Ranger DCB vs. uncoated balloon).
Primary safety endpoint was freedom from MAE and primary effectiveness endpoint was binary primary patency.
2. Kaplan-Meier Estimate: Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.
* At risk denotes the number subjects entered in the calculation at the time interval.
** Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
|Primary Safety Endpoint
(Freedom from MAE)
|Primary Effectiveness Endpoint
(Binary Primary Patency)
CD-TLR & Mortality
Compared to PTA, Ranger demonstrated:
- Significantly lower TLR
- No difference in mortality
4. Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
Ranger PK Substudy5
- Protocol required blood draws: Baseline, 10 minutes, 30 minutes 1, 3, 6, 24 or 48 hours.
- All 12 patients received Ranger DCB
- Average number of DCBs used per patient: 1.75
- Measurable level is 1.0 ng/ml.
5. RANGER II SFA PK Substudy presented by Ravish Sachar, MD. VIVA 2019.
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