Esprit BTK Device for Critical Limb Ischemia

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests Esprit BTK, a device for treating arteries below the knee. It targets patients with artery issues in this area, especially those not fully helped by other treatments. The device works by keeping the arteries open to improve blood flow.

Eligibility Criteria

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.

Inclusion Criteria

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.

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Exclusion Criteria

You have a metal stent implanted in the area of concern.

I have untreated or unsuccessfully treated artery blockages near my heart.

Note: staged procedures are not allowed in LIFE-BTK PK sub-study.

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Treatment Details

Interventions

Esprit BTK Device (Device)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Esprit BTKExperimental Treatment1 Intervention

Participants who receives Esprit BTK device will be included in this arm