Intraoperative Simultaneous Pressure Guided Revascularization Study

Completed

• Conditions: Endovascular Procedures; Clinical Decision-Making; Monitoring, Intraoperative; Peripheral Vascular Diseases; Blood Pressure
• Interventions: Diagnostic Test: Intraoperative Hemodynamic Pressures; Diagnostic Test: Contrast Flow Rate

• Registration Number: NCT03875846
• Lead Sponsor: Mark Rockley

Brief 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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Primary Completion: 2020-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intraoperative Hemodynamic Improvement	Contrast Flow Rate	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 Improvement	Intraoperative Hemodynamic Pressures	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Target Vessel Re-Intervention	1 Year	Endovascular, Open, Thrombectomy, Thrombolysis.
Target Vessel Patency	1 Year	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
Major Amputation	1 Year	Any ipsilateral leg amputation performed above the joint of the ankle.
Minor Amputation	1 Year	Any ipsilateral leg amputation performed distal to the joint of the ankle.
Post-Operative Hemodynamic Measurements	1 - 3 Months	Correlation between intraoperative completion and immediate post-operative measurements, with longer-term surveillance measurements
Improvement in Rutherford's Classification of Peripheral Vascular Disease	1 Year	Maximal documented categorical state following index revascularization

Trial Locations

Locations (1)

The Ottawa Hospital, Civic Campus; 🇨🇦 Ottawa, Ontario, Canada