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New treatment option for Vascular Diseases
Official title The ALOFT Pilot Trial
ClinicalTrials.gov ID: NCT06067789
What this study is testing
- What it's testing
- The ALOFT Pilot Trial will evaluate three pragmatic elements (recruitment, adherence, and follow-up) of neuraxial versus general anesthesia for lower limb revascularization surgery that are necessary to support a successful, large-scale evaluation. We will concurrently use implementation science methodology to further refine processes for the larger trial.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy...
- Able to access a telephone for postoperative follow-up
You likely can't join if
- Absolute contraindications to neuraxial anesthesia: impaired coagulation state (due to intrinsic, congenital or extrinsic (i.e., anticoagulant not...
- Traumatic arterial injuries as an indication for surgery
- Multiple sclerosis or demyelinating central nervous system conditions
- Known malignant hyperthermia or who require a malignant hyperthermia trigger-free anesthetic
- Pregnancy
- Prior enrollment in this study, or participating in another treatment trial that could interfere with interpretation of data for either study (may be...
See the full eligibility criteria
- Age ≥18 years
- Planned lower limb revascularization surgical procedure (on an elective or urgent basis): infrainguinal arterial bypass, femoral endarterectomy, patch angioplasty
- Able to access a telephone for postoperative follow-up
- Absolute contraindications to neuraxial anesthesia: impaired coagulation state (due to intrinsic, congenital or extrinsic (i.e., anticoagulant not held for guideline recommended period based on the American Society of...
- Traumatic arterial injuries as an indication for surgery
- Multiple sclerosis or demyelinating central nervous system conditions
- Known malignant hyperthermia or who require a malignant hyperthermia trigger-free anesthetic
- Pregnancy
- Prior enrollment in this study, or participating in another treatment trial that could interfere with interpretation of data for either study (may be acceptable if unrelated interventions/outcomes and study PIs mutually...
- Determination by the surgeon, anesthesiologist, or other clinician, that the patient would not be suitable for randomization
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.