Clinical trial NCT03321552: PROMISE International
Official title: Percutaneous Deep Vein Arterialization Post-Market Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Critical Limb Ischemia
Keywords: Desert foot
No-option patients
Venous arterialization
Lead sponsor: LimFlow SA
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

Detailed description: This study will investigate the safety and effectiveness of the LimFlow System for creating an arterio-venous fistula in the below-the-knee vascular system using an endovascular, minimally invasive approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Eligibility criteria: Inclusion Criteria:

* Subject must be \> 21 and \< 95 years of age
* Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6
* Assessment that no conventional surgical or endovascular treatment is possible
* Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be \<50% stenosed
* Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits

Exclusion Criteria:

* Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder
* Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study
* Life expectancy less than 12 months
* Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment
* Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment
* Patient currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment
* Patient unable to give consent
* Pregnant or breastfeeding women
* Documented myocardial infarction or stroke within previous 90 days
* Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis
* Patients with vasculitis and/or untreated popliteal aneurysms
* Patients with acute limb ischemia
* Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft
* Lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion
* Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)
* Known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
* Severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of \< 40%, NYHA Classification III-IV)

Primary outcomes:
measure: Amputation-free survival
timeFrame: Throughout one year
Secondary outcomes:
measure: Wound healing
timeFrame: Throughout one year
measure: Primary and secondary patency as assessed by duplex ultrasound
timeFrame: Throughout one year
measure: Limb salvage: Freedom from major amputation
timeFrame: Throughout one year
measure: Deterioration in renal function as assessed by creatinine level
timeFrame: One month and six months
measure: Technical success (procedure completion)
timeFrame: Immediately post-procedure
measure: Procedural success (technical success without death, major amputation, or re-intervention)
timeFrame: One month post-procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinikum Graz
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach
state: Baden-Württemberg
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg GmbH
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: St. Franziskus-Hospital GmbH
state: North Rhine-Westphalia
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Saxony
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
References:
citation: Schreve MA, Lichtenberg M, Unlu C, Branzan D, Schmidt A, van den Heuvel DAF, Blessing E, Brodmann M, Cabane V, Lin WTQ, Kum S. PROMISE international; a clinical post marketing trial investigating the percutaneous deep vein arterialization (LimFlow) in the treatment of no-option chronic limb ischemia patient. CVIR Endovasc. 2019 Jul 31;2(1):26. doi: 10.1186/s42155-019-0067-z.