NCT03875846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

March 13, 2019

Last Update Submit

August 2, 2021

Conditions

Peripheral Vascular DiseasesBlood PressureMonitoring, IntraoperativeClinical Decision-MakingEndovascular Procedures

Keywords

Intraoperative Decision MakingRevascularizationPhysiologic Monitoring Feedback

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Major Amputation

    1 Year

  • Minor Amputation

    1 Year

  • Target Vessel Re-Intervention

    1 Year

  • Target Vessel Patency

    1 Year

  • Improvement in Rutherford's Classification of Peripheral Vascular Disease

    1 Year

  • +1 more secondary outcomes

Other Outcomes (2)

  • Mortality

    1 Year

  • Amputation-Free Survival

    1 Year

Study Arms (1)

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.

Diagnostic Test: Intraoperative Hemodynamic PressuresDiagnostic Test: Contrast Flow Rate

Interventions

Intraoperative Hemodynamic PressuresDIAGNOSTIC_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.

Also known as: Toe Brachial Index, Ankle Brachial Index, Absolute Toe Pressure, Absolute Ankle Pressure
Intraoperative Hemodynamic Improvement
Contrast Flow RateDIAGNOSTIC_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.

Also known as: Time to Peak Opacification, Rate of Contrast Opacification, Wash-In Rate, Wash-Out Rate
Intraoperative Hemodynamic Improvement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital, Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 31444190DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Ankle Brachial Index

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure DeterminationDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • George Wells, PhD, MSc

    Cardiovascular Research Methods Centre, University of Ottawa Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 15, 2019

Study Start

October 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2021

Last Updated

August 4, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)