Clinical trial NCT03875846: Intraoperative Simultaneous Pressure Guided Revascularization Study
Official title: Intraoperative Simultaneous Pressure Guided Revascularization Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Diseases
Blood Pressure
Monitoring, Intraoperative
Clinical Decision-Making
Endovascular Procedures
Keywords: Intraoperative Decision Making
Revascularization
Physiologic Monitoring Feedback
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective or semi-urgent endovascular procedures for lower extremity de-novo atherosclerotic peripheral vascular disease. These patients will be treated at The Ottawa Hospital, Civic Campus, under the care of the Division of Vascular Surgery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Limb Event (MALE)
timeFrame: 1 Year
Secondary outcomes:
measure: Major Amputation
timeFrame: 1 Year
measure: Minor Amputation
timeFrame: 1 Year
measure: Target Vessel Re-Intervention
timeFrame: 1 Year
measure: Target Vessel Patency
timeFrame: 1 Year
measure: Improvement in Rutherford's Classification of Peripheral Vascular Disease
timeFrame: 1 Year
measure: Post-Operative Hemodynamic Measurements
timeFrame: 1 - 3 Months
Other outcomes:
measure: Mortality
timeFrame: 1 Year
measure: Amputation-Free Survival
timeFrame: 1 Year
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Civic Campus
state: Ontario
Study officials:
affiliation: Cardiovascular Research Methods Centre, University of Ottawa Heart Institute
name: George Wells, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rockley M, Jetty P, Wells GA. Protocol for a prospective observational diagnostic study: intraoperative simultaneous limb pressure monitoring (INSTANT) study. BMJ Open. 2019 Aug 22;9(8):e030456. doi: 10.1136/bmjopen-2019-030456.