PROMISE I – U.S. Feasibility Study


PROMISE I is a multi-center, prospective, single-arm study conducted at seven U.S. centers encompassing end-stage — or “no option” — CLTI patients. All patients were confirmed as “No-Option” and facing imminent amputation by an independent review committee of vascular surgeons. Patients were enrolled between July 2017 and April 2019.

Patient Demographics

32 Patients

PROMISE I - Demographics | amCharts

PROMISE I Study Results - U.S.
Rutherford class 5 or 6
Ineligible for endovascular or surgical procedures to restore blood flow

6-Month Outcomes1


PROMISE I - Primary Endpoint Amputation Free Survival | amCharts

PROMISE I Study Results - U.S.
Freedom from Amputation
Amputation-free survival
Technical success

Watch interview with PROMISE I PI Dan Clair, MD

1. Clair, Dan. “Results of the LimFlow System in the Promise I Trial” Vascular Interventional Advances Conference”. November 2019, The Wynn Las Vegas. Late Breaking Clinical Trial Presentation.

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