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PROMISE II – U.S. Pivotal Study

6 Month Study Results

PROMISE II is a landmark multi-center, prospective pivotal study of the LimFlow System conducted at 20 U.S. centers in 105 No-option CLTI patients typically excluded from other clinical studies. All patients were confirmed as “No-Option” and facing imminent amputation by an independent review committee of vascular surgeons. Patients were enrolled between December 2020 to March 2022. This study was a success and met its primary endpoint.

Patient Demographics

105 Patients

“Sickest population of CLTI patients ever enrolled in a pivotal trial.”

– Dr. Dan Clair, PROMISE II Co-PI

PROMISE II - Demographics | amCharts

Screen Shot 2022-10-07 at 1.21.50 PM
Ineligible for endovascular or surgical procedures to restore blood flow
Stable dialysis allowed
Rutherford class 5 and 6
99% technical success

Limb Salvage at 6 Months

Functional Limb Preservation in No-Option Patients

Wounds Healed or Healing at 6 Months

Wound Healing in Patients With Non-Healing Chronic Wounds

Primary Endpoint: 6 Month AFS, Limb Salvage, Survival

PromiseII 6-month chart

Amputation Free Survival (AFS) at 6 Months


Survival at 6 Months

Participating Sites:

Baylor College of MedicineSanger Heart & Vascular Institute
Boston Medical CenterSeton Heart Institute
Coastal Carolina SurgeryThe Cardiac and Vascular Institute
Dartmouth – Hitchcock Medical CenterUH Cleveland Medical Center
Harbor-UCLA Medical CenterUnityPoint Health
Mass General HospitalUniversity of California San Francisco
Ochsner Health CenterUniversity of Florida
Ponce Health Sciences UniversityVanderbilt University Medical Center
Prisma Health Upstate and MidlandsYale University
Saint Luke's Hospital of Kansas City

Thank you to all the investigators for your tremendous contribution to the PROMISE II pivotal trial.

Watch interview with Dan Clair, MD and Mehdi H. Shishehbor, DO, MPH, PhD

1. Clair, Dan. “Results of the LimFlow System in the Promise I Trial” Vascular Interventional Advances Conference”. November 2021, The Wynn Las Vegas. Late Breaking Clinical Trial Presentation.