Percutaneous Arterial disease
Conditions
Interventions
Group 1: Observational, retrospective data collection study
Sponsors
angiomed GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. The adult subject (= 18 years old) provides written informed consent (or where allowable the non-opposition process is followed on subjects that are not deceased). Note: Subjects may be enrolled without signing a consent form only if the responsible Ethics Committee (EC) has waived the requirement and written documentation about this decision has been provided to the principal investigator (PI) and the Sponsor, or where allowable according to the local regulations. 2. The subject had evidence of a hemodynamically relevant stenosis or restenosis =50% (as determined by the Investigator’s visual estimate) or occlusion in the SFA or popliteal artery and the vessel diameter was appropriate for treatment with one of the available study device implant sizes. 3. The subject’s lesion(s) was (were) treated with one or more of the LifeStent Family of devices no later than January 2019. 4. The subject has = 5 years of relevant follow-up information available for the initially treated target lesion(s). At minimum the following key clinical data must be available through 36 months: a. Information on study device implant related complications as defined for the primary safety endpoint. b. Information on MAEs. c. Information on reinterventions / revascularizations of the target lesion and / or target vessel. d. Clinical presentation status (Rutherford Classification, Fontaine Classification and / or assessment of clinical symptoms related to PAD).
Exclusion criteria
Exclusion criteria: 1. The study device was used outside of the indications of use (for example for the treatment of in-stent restenosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Assess the long-term clinical safety and effectiveness attributes of the LifeStent Family of devices when used for the treatment of atherosclerotic lesions in the SFA and popliteal artery •Safety Endpoint: oFreedom from implant-related complications through 36 months post-index procedure. •Effectiveness Endpoint: oFreedom from Target Lesion Revascularization (TLR) through 36 months post-index procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary • Safety o Assessing the long-term safety profile of the device • Effectiveness o Assessing the effectiveness of the study device with respect to its reintervention profile long-term. Secondary • Safety Endpoint: o Freedom from Major Adverse Events (MAEs) through 12, 24, 36, 48, and 60 months o Freedom from implant-related complications through 12, 24, 48, and 60 months post-index procedure. • Effectiveness Endpoints: o Freedom from TLR through 12, 24, 48, and 60 months post-index procedure. o Freedom from Target Vessel Revascularization (TVR) through 12, 24, 36, 48, and 60 months post-index procedure. | — |
Countries
France, Germany
Contacts
Public ContactMarcus Thieme
MEDINOS Kliniken des Landkreises Sonneberg GmbH
Outcome results
None listed