Clinical Investigation Plan (CIP) - LifeStent™ PMCF Study: A Retrospective 5-Year Assessment - BDPI LifeStent EU PMCF

angiomed GmbH0 个研究点目标入组 112 人开始时间: 2024年7月25日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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).

•1.The study device was used outside of the indications of use (for example for the treatment of in-stent restenosis).

发起方

angiomed GmbH