Intraoperative Simultaneous Pressure Guided Revascularization Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intraoperative Simultaneous Pressure Guided Revascularization Study

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

Intervention / Treatment
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* Diagnostic Test: Intraoperative Hemodynamic Pressures
* Diagnostic Test: Contrast Flow Rate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraoperative Hemodynamic Improvement<br>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. | Diagnostic Test: Intraoperative Hemodynamic Pressures<br>* 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.<br>* Other names: Absolute Ankle Pressure;Diagnostic Test: Contrast Flow Rate<br>* 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.<br>* Other names: Wash-Out Rate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Limb Event (MALE) | Composite outcome of major amputation above the ankle, major re-intervention in the form of catheter-directed thrombolysis, open bypass or thrombectomy. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Amputation | Any ipsilateral leg amputation performed above the joint of the ankle. | 1 Year | 
| Minor Amputation | Any ipsilateral leg amputation performed distal to the joint of the ankle. | 1 Year | 
| Target Vessel Re-Intervention | Endovascular, Open, Thrombectomy, Thrombolysis. | 1 Year | 
| Target Vessel Patency | Primary: Absence of target vessel occlusion or restenosis >50% Primary Assisted: Patency requiring assistance of subsequent procedure to maintain patency of target vessel Secondary: Patency requiring assistance of subsequent procedure to restore patency of target vessel | 1 Year | 
| Improvement in Rutherford's Classification of Peripheral Vascular Disease | Maximal documented categorical state following index revascularization | 1 Year | 
| Post-Operative Hemodynamic Measurements | Correlation between intraoperative completion and immediate post-operative measurements, with longer-term surveillance measurements | 1 - 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative Decision Making, Revascularization, Physiologic Monitoring Feedback