CompletedNot Applicable

Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

Austria, Belgium371 participantsStarted 2015-09-29

Plain-language summary

The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
✓. Rutherford Clinical Category 3-5;
✓. Patient is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits and recommended medication regimen;
✓. Significant stenosis (≥70%) or occlusion of one or more native artery(s) below the tibial plateau and above the tibiotalar joint appropriate for angioplasty per operator visual assessment;
✓. Lesion(s) can be treated with available Lutonix DCB device size matrix per current Instructions for Use (IFU); and
✓. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at least one patent (\<50% residual stenosis) inframalleolar outflow vessel (planned treatment below-the-ankle is not allowed).

Exclusion criteria

✕. Patient is currently participating in an investigational drug or device study which has not yet reached its primary endpoint or was previously enrolled into this registry (i.e. Lutonix BTK registry);
✕. Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast; or
✕. Neurotrophic ulcer or heel pressure ulcer or ulcer potentially involving calcaneus (index limb).

What they're measuring

Freedom from major adverse limb related events below the knee and of perioperative death.

Timeframe: 30-days

Rate of Target Lesion Revascularization (TLR)

Timeframe: 6 months

Trial details

NCT IDNCT02554266

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-05-31

View on ClinicalTrials.gov More Peripheral Artery Disease trials