SOLARIS Peripheral PMCF Trial (NCT04299906) | Clinical Trial Compass
UnknownNot Applicable
SOLARIS Peripheral PMCF Trial
Germany70 participantsStarted 2021-05-17
Plain-language summary
The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Corresponding to the IFU indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
* Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
* Patient presenting a score from 2 to 5 following Rutherford classification
* Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
* Patient is \>18 years old
* Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
* The target lesion is either a modified TASC-II class A, B, C or D lesion.
* The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
* There is angiographic evidence of a patent Common and Deep Femoral Artery
Exclusion Criteria:
* PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
* Presence of an aneurysm immediately adjacent to the site of stent implantation
* Stenosis distal to the site of stent implantation
* Lesions in or adjacent to essential collaterals(s)
* Lesions in locations subject to external compression
* Heavily calcified lesions resistant to PTA
* Patients with diffuse distal d…