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Drug-Eluting Stent
Esprit BTK Device for Critical Limb Ischemia (LIFE-BTK Trial)
N/A
Waitlist Available
Led By Ramon L Varcoe, MBBS, MS, FRACS, PhD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5
Non-target lesion(s) (if applicable) must be located in separate infrapopliteal vessel(s) from the target lesion, and suitable to be treated per institution standard of care
Must not have
Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to ADP antagonists such clopidogrel, prasugrel or ticagrelor; or to anticoagulants such as heparin or bivalirudin, and therefore cannot be adequately treated with study medications. Subject with planned surgery or procedure necessitating discontinuation of antiplatelet medications, within 12 months after index procedure. Planned amputation that will necessitate discontinuation of antiplatelet medications is allowed
Subject has had a stroke within the previous 3 months with residual Rankin score of ≥ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new device that will be used to treat narrowed arteries below the knee.
Who is the study for?
This trial is for adults with Critical Limb Ischemia needing treatment for leg artery blockages. Participants must not be pregnant, on birth control if applicable, and have no severe kidney issues or recent strokes. They should not be part of another study or have conditions that could interfere with the trial.
What is being tested?
The LIFE-BTK trial tests the Esprit BTK System, a device releasing everolimus to treat narrowed arteries below the knee, against standard balloon angioplasty. It's randomized and single-blinded at multiple international sites with a 2:1 participant ratio favoring the test device.
What are the potential side effects?
Potential side effects may include local reactions at the treatment site such as pain or bleeding, infection risk from invasive procedures, allergic reactions to materials in devices or medications used during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe leg pain from poor blood flow, classified as Category 4 or 5.
Select...
My non-target lesions are in different vessels from the target lesion and can be treated.
Select...
My lesion is in the upper part of my lower leg's vessels, fitting the size criteria.
Select...
I am not pregnant and am using birth control.
Select...
I need treatment for up to two new or previously treated blockages below my knee.
Select...
My treatment requires a scaffold no longer than 170 mm.
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I am 18 years old or older.
Select...
My major artery blockage was treated successfully before targeting the specific lesion.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to common blood thinners and cannot take them.
Select...
I had a stroke in the last 3 months and still have some disability.
Select...
I have had or will need treatment with a specific drug-coated device recently.
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I have untreated or unsuccessfully treated artery blockages near my heart.
Select...
I need complex surgery to save my foot due to extensive tissue loss.
Select...
I have a severe blockage in an artery that needs treatment.
Select...
My target lesion likely needs atherectomy for treatment.
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I have had or need surgery to improve blood flow in a limb, but not to the tibial arteries.
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I have had symptoms or tested positive for COVID-19 or a similar infection in the last 2 months.
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I am mentally capable and have the legal right to make my own health decisions.
Select...
My kidney function is low, with a GFR under 30 ml/min.
Select...
I do not have a working artery in my foot.
Select...
My lesions are severely calcified, making successful treatment difficult.
Select...
I am currently undergoing dialysis.
Select...
I need treatment for a blocked artery in my limb.
Select...
I have an aneurysm in a major artery of my leg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Efficacy Endpoint: Number of Participants With Composite of Limb Salvage and Primary Patency
Primary Safety Endpoint: Freedom From Major Adverse Limb Event + Peri-Operative Death Rate (MALE + POD)
Secondary study objectives
First Powered Secondary Endpoint: Binary Restenosis of the Target Lesion
Second Powered Secondary Endpoint: Freedom From Above Ankle Amputation in Index Limb, 100% Total Occlusion of the Target Vessel, and CD-TLR.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Esprit BTKExperimental Treatment1 Intervention
Participants who receives Esprit BTK device will be included in this arm
Group II: Percutaneous Transluminal Angioplasty (PTA)Active Control1 Intervention
Participants who receives PTA treatment will be included in this arm
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
652 Previous Clinical Trials
416,576 Total Patients Enrolled
Ramon L Varcoe, MBBS, MS, FRACS, PhDPrincipal InvestigatorPrince of Wales Private Hospital, Randwick, NSW, Australia
Brian DeRubertis, MD, FACSPrincipal InvestigatorNewYork-Presbyterian/Weill Cornell Medical Center, New York, NY
Sahil Parikh, MD, FACC, FSCAIPrincipal InvestigatorNew York Presbyterian Hospital, New York, NY
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to common blood thinners and cannot take them.I am undergoing or scheduled for cancer treatment around the time of my procedure, but have been in remission for 6 months if on chemotherapy.I had a stroke in the last 3 months and still have some disability.I have had a major limb amputation and cannot walk on my own.I am allergic to certain metals and plastics used in medical devices and cannot be treated for these allergies.I have had or will need treatment with a specific drug-coated device recently.I have untreated or unsuccessfully treated artery blockages near my heart.Your blood platelet count is too low or too high, or your white blood cell count is too low, or your hemoglobin level is too low.I have a severe infection in my limb with fever, high white blood cell count, or low blood pressure.I am bedridden or need help to walk, but I can move in a wheelchair on my own.I need complex surgery to save my foot due to extensive tissue loss.You have a body mass index (BMI) below 18.I have a severe blockage in an artery that needs treatment.The blood vessel being studied should not have any other major blockages.My lesions are close together and can be covered with a single treatment.My target lesion likely needs atherectomy for treatment.I have had or need surgery to improve blood flow in a limb, but not to the tibial arteries.I have a serious immune condition but am not on strong immune-weakening medicines, or my HIV is well-controlled.I have severe leg pain from poor blood flow, classified as Category 4 or 5.I have had symptoms or tested positive for COVID-19 or a similar infection in the last 2 months.The target area for treatment must be at least 10 cm above the ankle, and the blood vessel below the target area must be open all the way to the ankle without any major blockages.You have a lesion that was previously treated with a metal stent.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 lesion needs a specific treatment method involving scaffolding.My non-target lesions are in different vessels from the target lesion and can be treated.My lesion is in the upper part of my lower leg's vessels, fitting the size criteria.The doctor cannot widen the narrowed blood vessel based on what they see during the examination.I am not pregnant and am using birth control.I need treatment for up to two new or previously treated blockages below my knee.My treatment requires a scaffold no longer than 170 mm.I am a woman who can have children and I have a recent negative pregnancy test.I have confirmed blood clots in the arteries of one of my limbs.I am mentally capable and have the legal right to make my own health decisions.My kidney function is low, with a GFR under 30 ml/min.My targeted blood vessel is at least 70% blocked.I do not have a working artery in my foot.I have up to two blockages below my knee in different vessels of the same leg.My lesions are severely calcified, making successful treatment difficult.I am currently undergoing dialysis.The combined length of all target lesions must not be longer than 170 millimeters.I need treatment for a blocked artery in my limb.There is a visible blood clot in the blood vessels being studied.I have an aneurysm in a major artery of my leg.I am 18 years old or older.You are expected to live for less than 1 year.My major artery blockage was treated successfully before targeting the specific lesion.A wire was successfully placed through my blockage for treatment, preferably from the usual direction.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Esprit BTK
- Group 2: Percutaneous Transluminal Angioplasty (PTA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.