NCT03875846

Intraoperative Simultaneous Pressure Guided Revascularization Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Mark Rockley · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Peripheral Vascular Diseases
• Blood Pressure
• Monitoring, Intraoperative
• Clinical Decision-Making
• Endovascular Procedures

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Intraoperative Hemodynamic Pressures	Secondary analyses will examine the Ankle-Brachial Index, and the absolute limb pressures. In addition, the changes in flow rate of contrast before- and after- intervention will be examined as an indicator of perfusion.
DIAGNOSTIC_TEST	Contrast Flow Rate	A secondary analysis will examine the rate of contrast flow during pre-intervention and post-intervention angiograms, and correlate these findings with hemodynamic measurements recorded during surgery.

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-01-01
• Completion: 2021-01-01
• First posted: 2019-03-15
• Last updated: 2021-08-04

Locations

1 site across 1 country: Canada