Peripheral Arterial Disease
Conditions
Brief summary
The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery (scoring) and therefore promote a regular expansion of atheroma by balloon inflation.
Interventions
DEVICEFLEX Scoring Catheter
Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.
Sponsors
VentureMed Group Inc.
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
* Patients ≥ 18-year-old, with symptomatic lower extremity occlusive arterial disease * Rutherford class of symptom 2 to 5 * Atheromatous ≥ 70 % stenosis or occlusion of SFA and/or PA * Absence of \> 50% residual stenosis of the run-in vessels at the end of procedure * Presence of at least one patent (no ≥ 50 % stenosis) run-off tibial or fibular vessel to the foot at the end of procedure * De novo or restenotic lesions, including in-stent restenosis * Willingness to participate in the study and signature of informed consent
Exclusion criteria
* Renal failure with glomerular filtration rate (GFR) 30 ml/min or below, estimated by the Cockroft-Gault equation. * Women who are pregnant, lactating, or planning to become pregnant during the duration of the study * Recent artery thrombosis, at risk of distal embolization during percutaneous procedure * Previous use of a PCB in the lesion during last 15 months * Extremely calcified lesions, defined by calcification involving ³ 270° of the artery circumference over ³ 15 cm. * Sub-intimal recanalization * Tortuous contra-lateral femoral access with difficult cross-over * Previous or planned surgery of the target lesion * High risk of bleeding * Contra-indication to dual antiplatelet therapy for one month, and/or to single antiplatelet therapy for 1 year * Allergy to aspirin, clopidogrel or heparin * Life expectancy less than one year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of clinically driven target lesion revascularization (CDTLR) at 12 months | 12 months |
| Occurrence of death from cardiovascular origin | 12 months |
| Occurrence of major amputation of target limb | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in ankle brachial index (ABI) | 3 and 12 months |
| Change in Rutherford class of symptom | 3 and 12 Months |
| Technical success of the scoring procedure | Average of 2 hours |
| Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan) | 3 and 12 months |
| Occurrence of dissection | Average of 2 hours |
| Proportion of stent implantation | Average of 2 hours |
| Proportion of luminal gain | Average of 2 hours |
| Absence of CDTLR | 3 months |
| Absence of major amputation | 3 and 12 months |
Countries
Switzerland
Outcome results
None listed