Intraoperative Simultaneous Pressure Guided Revascularization Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-01-01

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.

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intraoperative Hemodynamic Improvement

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.

Intraoperative Hemodynamic Pressures

Intervention Type DIAGNOSTIC_TEST

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.

Contrast Flow Rate

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Toe Brachial Index Ankle Brachial Index Absolute Toe Pressure Absolute Ankle Pressure Time to Peak Opacification Rate of Contrast Opacification Wash-In Rate Wash-Out Rate

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No