Peripheral Arterial Occlusive Disease
Conditions
Brief summary
The aim of the study is to assess the safety and efficacy of the Multi-LOC® peripheral stent system to treat de novo and restenotic lesions (no in-stent restenosis (ISR), no restenosis post drug coated balloon (DCB) after flow limiting plain old balloon angioplasty (POBA) and/or DCB dilatations in the superficial femoral artery (SFA) and popliteal segments (P1, P2 & P3)
Detailed description
This study is an non-randomized, prospective, multi-center, non-interventional study (registry, for Germany: §23b MPG)
Interventions
DEVICEVascuFlex Multi-LOC®
Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty
Sponsors
Deaconess Hospital Mannheim
B. Braun Melsungen AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willingness to treat flow-limiting dissections/recoil after plain old balloon angioplasty (POBA)/drug coated balloon (DCB) interventions * Patients in Rutherford classes 2 through 5 * Patients eligible for peripheral revascularization by means of percutaneous transluminal angioplasty (PTA) and stenting * Patients must be at least 18 years of age * Patient with a life expectance of at least 12 months * Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol * Patients must agree to undergo at least the 6-month clinical follow-up * Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of other suitable stent devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document. * Lesions with unsatisfying angiographic results due to recoil and/or dissections after POBA/DCB interventions * Infra-inguinal lesions in the superficial femoral artery (SFA) and popliteal segments (P1,P2 & P3) reference vessel diameters between 4 and 7.0 mm, lesion length suitable for the release of at least 2 Stent (up to 6) segments implanted with a minimum inter-stent distance of 1 cm * Diameter stenosis pre-procedure must be larger or equal to 70% * Vessels must have adequate distal run-off with at least one vessel to the foot or with collaterals in the calf supplying sufficient flow to the foot. (Lesions separated by less than 2 cm are considered as one lesion)
Exclusion criteria
* Patient not suitable for revascularization by interventional means
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| target lesion revascularization | 6 months | target lesion revascularization surgical & interventional |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximum walking distance | < 3 weeks, 6 months, 12 months | maximum walking distance |
| target lesion revascularization | 12 months | target lesion revascularization |
| patency rates | 6 and 12 months | patency rates observed using non-invasive Duplex ultrasound |
| Rutherford classification | baseline, < 3 weeks, 6 months, 12 months | Rutherford classification |
| pain free walking distance | < 3 weeks, 6 months, 12 months | pain free walking distance |
| Rutherford classification shift | < 3 weeks, 6 months, 12 months | difference in Rutherford classification compared to previous time point |
| amputation rate | 6 and 12 months | rate of major and minor amputations |
| procedural success | immediately after Multi-LOC implantation (within the first 30 minutes) | procedural success to pass and treat the target lesion |
| ankle brachial index | < 3 weeks, 6 months, 12 months | ankle brachial index |
| quality of life assessment | 6 and 12 months | quality of life assessment through validates CRF's |
Countries
Germany
Outcome results
None listed