Intraoperative Simultaneous Pressure Guided Revascularization Study

Blood Pressure Clinical Trial

— INSTANT  

Official title:

Intraoperative Simultaneous Pressure Guided Revascularization Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875846
• Other study ID #: 20180656-01H
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2021
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital, Civic Campus	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mark Rockley

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	As captured by the hospital's Electronic Health Record	1 Year
Other	Amputation-Free Survival	Survival free of major amputation.	1 Year
Primary	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	Major Amputation	Any ipsilateral leg amputation performed above the joint of the ankle.	1 Year
Secondary	Minor Amputation	Any ipsilateral leg amputation performed distal to the joint of the ankle.	1 Year
Secondary	Target Vessel Re-Intervention	Endovascular, Open, Thrombectomy, Thrombolysis.	1 Year
Secondary	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
Secondary	Improvement in Rutherford's Classification of Peripheral Vascular Disease	Maximal documented categorical state following index revascularization	1 Year
Secondary	Post-Operative Hemodynamic Measurements	Correlation between intraoperative completion and immediate post-operative measurements, with longer-term surveillance measurements	1 - 3 Months