INSTANT: Intraoperative Simultaneous Pressure Guided Revascularization Study

Sponsor
Mark Rockley (Other)
Overall Status
Completed
CT.gov ID
NCT03875846
Collaborator
(none)
80
1
27
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Intraoperative Hemodynamic Pressures
  • Diagnostic Test: Contrast Flow Rate

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 Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Intraoperative Simultaneous Pressure Guided Revascularization Study
Actual Study Start Date :
Oct 1, 2018
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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 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.
Other Names:
  • Toe Brachial Index
  • Ankle Brachial Index
  • Absolute Toe Pressure
  • Absolute Ankle Pressure
  • 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.
    Other Names:
  • Time to Peak Opacification
  • Rate of Contrast Opacification
  • Wash-In Rate
  • Wash-Out Rate
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Major Amputation [1 Year]

      Any ipsilateral leg amputation performed above the joint of the ankle.

    2. Minor Amputation [1 Year]

      Any ipsilateral leg amputation performed distal to the joint of the ankle.

    3. Target Vessel Re-Intervention [1 Year]

      Endovascular, Open, Thrombectomy, Thrombolysis.

    4. 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

    5. Improvement in Rutherford's Classification of Peripheral Vascular Disease [1 Year]

      Maximal documented categorical state following index revascularization

    6. Post-Operative Hemodynamic Measurements [1 - 3 Months]

      Correlation between intraoperative completion and immediate post-operative measurements, with longer-term surveillance measurements

    Other Outcome Measures

    1. Mortality [1 Year]

      As captured by the hospital's Electronic Health Record

    2. Amputation-Free Survival [1 Year]

      Survival free of major amputation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ottawa Hospital, Civic Campus Ottawa Ontario Canada K1Y 4E9

    Sponsors and Collaborators

    • Mark Rockley

    Investigators

    • Principal Investigator: George Wells, PhD, MSc, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mark Rockley, Study Coordinator, University of Ottawa
    ClinicalTrials.gov Identifier:
    NCT03875846
    Other Study ID Numbers:
    • 20180656-01H
    First Posted:
    Mar 15, 2019
    Last Update Posted:
    Aug 4, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mark Rockley, Study Coordinator, University of Ottawa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2021