PROMISE International

Critical Limb Ischemia Clinical Trial

Official title:

Percutaneous Deep Vein Arterialization Post-Market Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03321552
• Other study ID #: EU PMS Revision 4.1
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: January 24, 2025

Study information

• Verified date: January 2024
• Source: LimFlow SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: January 24, 2025
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 95 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia

Intervention

Procedure:
• Percutaneous deep vein arterialization
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

Device:
• LimFlow System
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

Locations

Country	Name	City	State
Austria	Universitätsklinikum Graz	Graz
Germany	Klinikum Arnsberg GmbH	Arnsberg	North Rhine-Westphalia
Germany	Universitätsklinikum Heidelberg	Heidelberg	Baden-Württemberg
Germany	SRH Klinikum Karlsbad-Langensteinbach	Karlsbad	Baden-Württemberg
Germany	Universitätsklinikum Leipzig	Leipzig	Saxony
Germany	St. Franziskus-Hospital GmbH	Münster	North Rhine-Westphalia
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	St. Antonius Hospital	Nieuwegein
New Zealand	Auckland City Hospital	Auckland
Singapore	Changi General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
LimFlow SA

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  New Zealand,  Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation-free survival	Freedom from death or major amputation	Throughout one year
Secondary	Wound healing	Complete index wound healing as assessed by wound pictures	Throughout one year
Secondary	Primary and secondary patency as assessed by duplex ultrasound	Stent graft patency as assessed by duplex ultrasound	Throughout one year
Secondary	Limb salvage: Freedom from major amputation	Freedom from major amputation	Throughout one year
Secondary	Deterioration in renal function as assessed by creatinine level	Changes in creatinine level	One month and six months
Secondary	Technical success (procedure completion)	Procedure completion and immediate morphological success with successful placement of the arterial and venous catheters in the desired location in the limb, and ability to place the stent graft	Immediately post-procedure
Secondary	Procedural success (technical success without death, major amputation, or re-intervention)	Combination of technical success without death, major amputation, or re-intervention	One month post-procedure