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Device
Esprit BTK Device for Critical Limb Ischemia
N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment of the angiography) through standard of care prior to the treatment of the target lesion. Treatment must be done within the same trial procedure. Treatment allowed for inflow artery lesions are PTA, atherectomy, cutting/scoring balloon, Shockwave balloon, bare metal stent, drug-eluting stents or drug-coated balloon. Everolimus-coated or eluting devices are not allowed.
Subject must be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 60 days
Awards & highlights
Study Summary
This trial will enroll 7 subjects in the US and outside the US to study the use of the Esprit BTK device in below the knee arteries. 4 subjects will be treated without the use of drug-coated balloons (DCB) while 3 subjects will be treated with DCB.
Who is the study for?
This trial is for adults with symptomatic Critical Limb Ischemia, specifically Rutherford Becker Clinical Category 4 or 5. Participants must have specific types of leg artery blockages and be able to undergo the procedure as described. Pregnant women, those on certain other medications, or with conditions like severe allergies to device materials, recent strokes, renal insufficiency, or a short life expectancy cannot join.Check my eligibility
What is being tested?
The LIFE-BTK PK Sub-study is testing the Esprit BTK Device in patients who haven't used drug-coated balloons (DCB) and those who have. It's not randomized; about seven people will get this device implanted in their below-the-knee arteries at up to five sites in the US.See study design
What are the potential side effects?
While specific side effects are not listed for this sub-study, potential risks may include reactions to device materials such as everolimus and polymers used in the scaffold, bleeding due to antiplatelet medication requirements post-procedure, infection risk from surgery and local irritation or inflammation at implant site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had successful treatment for a major blockage in my artery before joining this trial.
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I am 18 years old or older.
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I am not pregnant and am using birth control.
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My lesion is in the upper part of my lower leg's main arteries and is between 2.5 and 4.00 mm wide.
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I have severe leg pain from poor blood flow, classified as Category 4 or 5.
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I need treatment for a new or previously treated blockage below my knee.
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My treatment requires a specific device length to cover the affected area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 to 60 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 60 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC 0-infinity
AUC Last/AUC0-t
AUC0-24h
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Esprit BTKExperimental Treatment1 Intervention
Participants who receives Esprit BTK device will be included in this arm
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
404,486 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a metal stent implanted in the area of concern.I have untreated or unsuccessfully treated artery blockages near my heart.My wound affects the heel bone.I have deep foot wounds exposing tendon or bone.The blood vessels being studied show signs of blood clots in the images.My doctor thinks I'll likely need a procedure to remove plaque from my artery.I am undergoing or scheduled for cancer treatment around the time of my procedure.I have a large sore (> 3 cm) on the bottom of my foot.I am mentally capable and have the legal right to make my own decisions.I had a procedure with an everolimus-eluting device for heart or artery issues.I have confirmed blood clots in the arteries of one of my limbs.My non-targeted leg vein issues can be treated without affecting the main treatment area.My treatment area is well above my ankle and any narrowings below it have been treated.I've had successful treatment for a major blockage in my artery before joining this trial.I have a blood clotting disorder that could lead to artery blockages, but I can join if I only have deep vein clot risks.My bone infection is limited to my toes or the balls of my feet.My condition involves severely calcified lesions that are hard to treat.I have an aneurysm in a major artery of my leg.Any significant blockages in my blood vessels have been or will be treated before the target treatment.I am allergic to common blood thinners and cannot take them.I am bedridden or need help to walk, but I can move in a wheelchair on my own.My kidney function is low, with a GFR under 30.Your blood platelet count, white blood cell count, or hemoglobin levels are outside the normal range.I have a serious immune condition but am not on strong immune-suppressing drugs, or my HIV is well-controlled.You have a very low body weight for your height.My wound is caused by nerve damage and not by poor blood flow.I am 18 years old or older.I have a wound that needs complex care or surgery to cover.My lesion needs a specific treatment method involving scaffolding.I am currently undergoing dialysis.I need treatment for a blocked artery in my limb.I had a stroke in the last 3 months and still have some difficulties.I have had an amputation other than toe or forefoot on one side, or a major amputation on the opposite side within the last year and cannot walk on my own.My targeted blood vessel is at least 70% blocked.My treatment will be given in the direction of blood flow.I am allergic to certain materials like everolimus and metals used in medical devices that can't be managed with medication.I have a deep heel ulcer that may or may not affect the heel bone.I am not pregnant and am using birth control.The doctor cannot widen the narrowed area in the blood vessel based on what they see.I have one or more blockages below my knee, including new or previously treated ones.I need complex foot surgery due to extensive tissue loss.My lesion is in the upper part of my lower leg's main arteries and is between 2.5 and 4.00 mm wide.My treatment involves covering the diseased area with a device no longer than 256 mm.I have a severe infection in my limb with fever, high white cell count, or low blood pressure.Your doctor expects you to live for less than one year.My foot's main artery is not open.I have gangrene on the bottom of my foot.I have had or need surgery to improve blood flow in a limb, but not to the tibial arteries.I have had COVID-19 symptoms or a positive test within the last 2 months.I have severe leg pain from poor blood flow, classified as Category 4 or 5.I need treatment for a new or previously treated blockage below my knee.My treatment requires a specific device length to cover the affected area.
Research Study Groups:
This trial has the following groups:- Group 1: Esprit BTK
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many health facilities are currently participating in this trial?
"This clinical trial is being conducted across 8 sites, including First Coast Cardiovascular Institute in Jacksonville, Florida; Charlton Memorial Hospital in South Dartmouth, Massachusetts; and Ascension St. John Jane Phillips in Bartlesville, Oklahoma."
Answered by AI
What is the current participant quota for this research study?
"This study requires a total of 7 participants who meet the prerequisites. The trial is running at multiple locations, including First Coast Cardiovascular Institute in Jacksonville and Charlton Memorial Hospital in South Dartmouth."
Answered by AI
Is there still an opportunity to enroll in this clinical experiment?
"The trial is still open to patients, as the information on clinicaltrials.gov indicates it was recently updated in October of 2022 and initially posted February 10th 2022."
Answered by AI
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