Peripheral Vascular DiseasesINSTANTNCT03875846
Intraoperative Simultaneous Pressure Guided Revascularization Study
An observational study of Peripheral Vascular Diseases and Blood Pressure, run by Mark Rockley at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Blood Pressure, Monitoring, Intraoperative
- What is being tested?
- Intraoperative Hemodynamic Pressures and Contrast Flow Rate
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Peripheral Vascular Diseases, Blood Pressure, Monitoring, Intraoperative, Clinical Decision-Making, Endovascular Procedures
- Being tested
- Intraoperative Hemodynamic Pressures, Contrast Flow Rate
- Keywords
- Intraoperative Decision Making, Revascularization, Physiologic Monitoring Feedback
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Hemodynamic PressuresDiagnostic test
Also called Toe Brachial Index, Ankle Brachial Index, Absolute Toe Pressure, Absolute Ankle Pressure
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 RateDiagnostic test
Also called Time to Peak Opacification, Rate of Contrast Opacification, Wash-In Rate, Wash-Out 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Intraoperative Hemodynamic Pressures; Diagnostic Test: Contrast Flow Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
Secondary outcomes (6)
Major Amputation
Any ipsilateral leg amputation performed above the joint of the ankle.
Measured: 1 Year
Minor Amputation
Any ipsilateral leg amputation performed distal to the joint of the ankle.
Measured: 1 Year
Target Vessel Re-Intervention
Endovascular, Open, Thrombectomy, Thrombolysis.
Measured: 1 Year
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
Measured: 1 Year
Improvement in Rutherford's Classification of Peripheral Vascular Disease
Maximal documented categorical state following index revascularization
Measured: 1 Year
Post-Operative Hemodynamic Measurements
Correlation between intraoperative completion and immediate post-operative measurements, with longer-term surveillance measurements
Measured: 1 - 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Oct 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Rockley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Rockley, University of Ottawa
- Investigators
- George Wells, PhD, MSc, Principal investigator, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875846
- Sponsor's protocol ID
- 20180656-01H
- Acronym
- INSTANT
- Status last verified
- Aug 2021
- First submitted
- 13 Mar 2019
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31444190
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Simultaneous Pressure Guided Revascularization Study
- ClinicalTrials.gov ID
- NCT03875846
- Acronym / sponsor ID
- INSTANT / 20180656-01H
- Conditions
- Peripheral Vascular Diseases, Blood Pressure, Monitoring, Intraoperative, Clinical Decision-Making, Endovascular Procedures
- Keywords
- Intraoperative Decision Making, Revascularization, Physiologic Monitoring Feedback
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mark RockleyUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Hemodynamic Improvement | – | Diagnostic Test: Intraoperative Hemodynamic Pressures, Diagnostic Test: Contrast Flow RateThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Hemodynamic PressuresAlso: Toe Brachial Index, Ankle Brachial Index, Absolute Toe Pressure, Absolute Ankle PressureSecondary 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. | Diagnostic test | Intraoperative Hemodynamic Improvement |
| Contrast Flow RateAlso: Time to Peak Opacification, Rate of Contrast Opacification, Wash-In Rate, Wash-Out RateA 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. | Diagnostic test | Intraoperative Hemodynamic Improvement |
Primary outcome
Major Adverse Limb Event (MALE)
Time frame: 1 Year
Composite outcome of major amputation above the ankle, major re-intervention in the form of catheter-directed thrombolysis, open bypass or thrombectomy.
6 secondary outcomes
Major Amputation
Time frame: 1 Year
Minor Amputation
Time frame: 1 Year
Target Vessel Re-Intervention
Time frame: 1 Year
Target Vessel Patency
Time frame: 1 Year
Improvement in Rutherford's Classification of Peripheral Vascular Disease
Time frame: 1 Year
Post-Operative Hemodynamic Measurements
Time frame: 1 - 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Derived from this study: PubMed 31444190Rockley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Wells, PhD, MSc principal investigator
Cardiovascular Research Methods Centre, University of Ottawa Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases and Blood Pressure, run by Mark Rockley at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Limb Event (MALE) (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.