NCT03970538: PROMISE

PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

Status unknown NA Results posted Last updated 28 February 2024

What this trial tests

NA trial testing LimFlow System in Critical Limb Ischemia in 105 participants. Status unknown.

Timeline

6 December 2019

Primary endpoint
9 September 2022

28 February 2025

Quick facts

Lead sponsor	LimFlow, Inc.
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	6 December 2019
Primary completion	9 September 2022
Estimated completion	28 February 2025
Sites	21 locations across Puerto Rico, United States

Drugs / interventions tested

• LimFlow System

Conditions studied

• Critical Limb Ischemia — all drugs for Critical Limb Ischemia →
• Critical Lower Limb Ischemia — all drugs for Critical Lower Limb Ischemia →
• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →
• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

LimFlow, Inc.

Who can join

Adults 18 to 95, any sex, with Critical Limb Ischemia or Critical Lower Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Amputation Free Survival (AFS) Primary · 6 months post-procedure

freedom from major amputation and death at 6 months, compared to a historical performance goal.

Group	Value	95% CI
Treatment	66

Primary Patency Secondary · 30 days post procedure

Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.

Group	Value	95% CI
Treatment	68

Primary Assisted Patency Secondary · 6 months post-procedure

Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred.

Group	Value	95% CI
Treatment	45

Secondary Patency Secondary · 30 days post-procedure

Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.

Group	Value	95% CI
Procedure Time	95

Limb Salvage Secondary · 30 days post-procedure

The percentage of subjects with freedom from above-ankle amputation of the index limb.

Group	Value	95% CI
Procedure Time	94

Change in Rutherford Classification Secondary · 30 days post-procedure

A decrease in Rutherford class number (i.e.: from Rutherford class 5 to 4) is clinical improvement

Group	Value	95% CI
Procedure Time	18

Technical Success Secondary · Immediately post-procedure

The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success.

Group	Value	95% CI
Treatment	104

Procedure Success Secondary · 30 days post-procedure

Combination of Technical Success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft.

Group	Value	95% CI
Treatment	77

Target Wound Healing Secondary · 30 days post-procedure

Complete healing of the patient's target wound

Group	Value	95% CI
Procedure Time	4

All Wound Healing Secondary · 30 days post-procedure

Complete healing of the patient's wounds.

Group	Value	95% CI
Procedure Time	4

Freedom From Contrast-Induced Nephropathy Secondary · Within the first 72 hours post-procedure

Subjects without acute (within 72 hours after intravenous contrast administration) impairment of renal function, measured as an absolute ≥0.5 mg/dL (44 µmol/L) increase compared to baseline SCr value that results in a value above the upper limit of the normal range.

Group	Value	95% CI
Treatment	103

Procedure Time Secondary · Immediately post-procedure

Time from the first puncture (venous or arterial) to when the last catheter is removed

Group	Value	95% CI
Procedure Time	217	± 87.77

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 68/105 (65%)

Deaths: 12/105

Serious adverse events (11 terms)

Reaction	System	Treatment
Gangrene	Infections and infestations	—
Osteomyelitis	Infections and infestations	—
Incision site impaired healing	General disorders	—
Sepsis	Infections and infestations	—
Wound Infection	Infections and infestations	—
Wound Complication	Injury, poisoning and procedural complications	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Peripheral ischemia	Vascular disorders	—
Gastrointestinal Hemorrhage	Gastrointestinal disorders	—
Acute kidney injury	Renal and urinary disorders	—
Debridement	Skin and subcutaneous tissue disorders	—

Other adverse events (15 terms — click to expand)

Reaction	System	Treatment
Vascular stent occlusion	Vascular disorders	—
Gangrene	Infections and infestations	—
Osteomyelitis	Infections and infestations	—
Wound infection	Infections and infestations	—
Foot amputation	Surgical and medical procedures	—
Wound complication	Injury, poisoning and procedural complications	—
Vascular stent occlusion	General disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Toe amputation	Surgical and medical procedures	—
Sepsis	Infections and infestations	—
Impaired healing	General disorders	—
Acute kidney injury	Renal and urinary disorders	—
Debridement	Surgical and medical procedures	—
Peripheral Ischemia	Vascular disorders	—
Incision site impaired healing	General disorders	—

Most-reported serious reactions: Gangrene, Osteomyelitis, Incision site impaired healing, Sepsis, Wound Infection, Wound Complication, Pain in extremity, Peripheral ischemia.

Data from ClinicalTrials.gov NCT03970538 adverse events section.

Sponsor's own description

The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular treatment option (i.e., "no option").

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia.
   Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, et al · · 2023 · cited 92× · PMID 36988592 · DOI 10.1056/nejmoa2212754
2. Contemporary outcomes in no-option chronic limb-threatening ischemia.
   Dua A, Powell RJ, Lee AC, Bernardo N, et al · · 2025 · cited 4× · PMID 40628923 · DOI 10.1038/s41598-025-09784-4