Intraoperative Simultaneous Pressure Guided Revascularization Study (INSTANT)

Mark Rockley

Status: Completed

Conditions: Monitoring, Intraoperative; Peripheral Vascular Diseases; Clinical Decision-Making; Blood Pressure; Endovascular Procedures

Treatments: Diagnostic Test: Intraoperative Hemodynamic Pressures; Diagnostic Test: Contrast Flow Rate

Study type: Observational

Funder types: Other

Identifiers

NCT03875846

20180656-01H

Details and patient eligibility

About

This study aims to determine whether intraoperative physiologic measurements of blood flow to the leg during endovascular treatment of Peripheral Arterial Disease (PAD) can predict future clinical outcomes.

Full description

Lower extremity peripheral arterial disease (PAD) caused by atherosclerosis can cause cause leg pain, gangrene, and limb loss. PAD is a result of poor blood flow to the extremity, and the emerging most common initial method of interventional treatment is endovascular therapy, for example angioplasty or stenting. The poor blood flow to the extremity can be inferred by the hemodynamic pressure of blood in the leg. These toe or ankle pressure measurements are typically performed before surgery to diagnose PAD, and after surgery as surveillance.

However, endovascular treatment has a high failure rate often exceeding 20% within a year. There is evidence that physiologic measurements prior to treatment and after treatment are closely related to clinical outcomes. This study introduces these physiologic measurements to the operating room, to determine if physiologic improvement can be detected instantaneously during endovascular revascularization. Patients will be followed for a year following surgery to detect hemodynamic and clinical outcomes. The rationale of these intraoperative measurements would be to potentially guide future surgery, by providing real-time hemodynamic feedback to the operator.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective or semi-urgent endovascular procedures on lesions of the aorta, iliac, femoral, popliteal, or tibial arteries
• Symptomatic, atherosclerotic Peripheral Vascular Disease. These symptoms include any Rutherford's classification.

Exclusion criteria

• Concurrent hybrid open procedure during endovascular revascularization requiring vascular clamping for any period of time, such as endarterectomy
• Prior open vascular surgery performed on the affected leg
• Emergent intervention for Acute Limb Ischemia, defined as symptoms lasting less than 14 days
• Non-femoral vascular access

Trial design

80 participants in 1 patient group

Intraoperative Hemodynamic Improvement

Description:

The primary outcome will examine the magnitude of change in the Toe-Brachial Index (TBI) between the beginning and the end of the procedure. The two measurements will be taken before- and after- vascular sheaths had been placed.

Treatment:

Diagnostic Test: Contrast Flow Rate

Diagnostic Test: Intraoperative Hemodynamic Pressures