Critical Limb Ischemia (CLI)
Conditions
Brief summary
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease. The aim of this study is to investigate if the RFS can be implanted safely and with technical success. Up to 10 subjects will be treated with the RFS at one investigational site. Lesions within the inflow trajectory or side branches may be treated with institutions standard of care prior to treatment of the target lesion. This may include usage of POBA, BMS, DCB, or DES. The target lesion will be predilated with POBA. Device safety will be assessed throughout the clinical investigation, with primary safety endpoints defined as freedom from Major Adverse Limb Events (MALE) at 30 days follow-up. In addition, MALE at 3-, 6-, 12-, and 24- months follow-up, all adverse events, serious adverse events and all device deficiencies will be captured as secondary endpoints. Device performance will be based on technical success of the implantation defined as successful delivery and deployment with a residual area stenosis of ≤50% as determined on final perioperative IVUS. Primary patency at day of discharge, 30-days, 3-, 6-, 12-, and 24- months follow up will be captured as secondary performance endpoint and are based on duplex ultrasound for all timepoints and angiography and IVUS at 6-months follow-up.
Interventions
DEVICEImplantation of RFS
Percutaneous transluminal implantation of the RFS in the infrapopliteal lesion
Sponsors
Stentit
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General inclusion criteria: 1. Subject must provide written informed consent prior to any clinical investigation related procedures. 2. Subject is willing and able to comply with the study procedures, and follow-up schedule. 3. Subject has Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5 4. Subject must be at least 18 years of age. Anatomical inclusion criteria: 5. Target lesion located in the tibioperoneal trunk, or 2/3 proximal part of the anterior tibial artery, posterior tibial artery or peroneal artery. 6. Only one target lesion per subject is included, other lesions can be treated per institution's standard of care. 7. At least one infrapopliteal branch without an angiographic significant lesion (≥50% diameter stenosis by angiography). 8. Vessel diameter of 3.0 mm to 3.4 mm. Quantitative imaging (IVUS and angiography) will be used to aid accurate sizing of the vessels. 9. Target lesion length ≤ 18 mm. 10. Target lesion of ≥70% diameter stenosis, per angiographic assessment at the time of the procedure. 11. Target lesion is in an area that may be stented without blocking access to subject main branches, i.e ≥2 mm distanced from any bifurcation. 12. Successful antegrade crossing of the target lesion
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD) | 30 day follow-up | Safety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD) * MALE includes: * Above ankle amputation in index limb or Any target lesion re-intervention at 30-day follow-up * POD includes: Mortality at 30 days follow-up |
| Performance: Number of patients with Technical Success | perioperative | Technical success is defined as successful delivery and deployment of the RFS to the target lesion resulting in a final residual area stenosis of ≤50% as assessed on intravascular ultrasound (IVUS). * Successful delivery is defined as reaching the target lesion and successful withdrawal of the delivery catheter. * Successful deployment is determined by the achieved pressure (in atm) on the balloon combined with visual assessment of the balloon inflation on angiography. * ≤50% residual area stenosis is verified by independent Core Lab analysis of perioperative IVUS measurements. If IVUS is not available or insufficient, ≤30% final residual diameter stenosis at perioperative angiography will be used to assess Technical Success. |
Countries
Austria
Contacts
Primary ContactKim van Noort, PhD
Outcome results
None listed