Iliac Artery Disease, Peripheral Artery Disease
Conditions
Brief summary
This PMCF study is designed as prospective, multi-center study to collect real-life data. The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1 of the following devices from AndraTec were used: The LOKUM-Quest guidewire, The LOKUM AMPLATZ guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA balloon, the AltoSa-XL GEMINI PTA Balloon, the OPTIMUS CoCr Stent , the OPTIMUS-CVS PTFE-Covered stent.
Interventions
DEVICE1 or more AndraTec devices (see description for list of devices)
1 or more AndraTec devices (Lokum L-Quest guidewire, Lokum Amplatz guidewire, Slider Hydrophilic Nitinol Guidewire, AltoSa-XL PTA Balloon, Alto-Sa-XL Gemini Balloon, Optimus-CoCr stent, Optimus-CVS PTFE covered stent)
Sponsors
Dr. Sabrina Overhagen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions. Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study (depending on the used device during the procedure) Patient is \>18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is eligible for treatment with * the Lokum L-Quest guidewire * and/or the Lokum Amplatz guidewire * and/or the Slider Hydrophilic Nitinol Guidewire * and/or the AltoSa-XL PTA balloon * and/or the AltoSa-XL Gemini balloon catheter * and/or the Optimus-XL CoCr Bare Metal Stent * and/or the Optimus-XL CVS PTFE Covered Stent, as described in the IFU for each device.
Exclusion criteria
* Application in coronary, cerebral arteries and central circulatory system * Known contraindication to peripheral arterial and visceral vasculature treatment - Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices. * Known contraindication and/or allergy to (a component of) an investigational device * Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding * Life expectancy of less than twelve months * Any planned surgical intervention/procedure within 30 days of the study procedure * Any patient considered to be hemodynamically unstable at onset of procedure * Patient is currently participating in another investigational drug or device study that has not completed the entire follow-up period. Device-related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure | during procedure | MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion) |
| Technical success rate | during procedure | defined as successfully introduction and deployment of the Lokum L-Quest, and/or the Lokum Amplatz, and/or the Slider Hydrophilic Nitinol Guidewire, and/or the Optimus CoCr Stent, and/or the Optimus PFTE covered BE Stent, and/or the AltoSa-XL-PTA, and/or the AltoSa-XL-Gemini Balloon Catheter according to the respective IFU and without device related deficiencies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from MACE post-procedure, after 6- and 12-months. | Through study completion, an average of 1 year | MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion) |
| For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from Device-related serious adverse events (SAE's) post-procedure, after 6- and 12-months | Through study completion, an average of 1 year | Freedom from Device-Related serious adverse events (SAE's) |
| Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months | Through study completion, an average of 1 year | Defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge. |
Outcome results
None listed