multi LOC Dr. Amendt LINC 2017 A FV ML 6 Mo results
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6-month results of the LOCOMOTIVE registry investigating spot stenting in the femoropopliteal tract Klaus Amendt Beschorner U, Thalwitzer J, Waliszewski M, Redlich U, Vogel B, Härtel D Hansen A and Langhoff R Center of Vascular Medicine „Oberrhein“ (Mannheim – Speyer) Clinic for Internal Medicine I: Angiology, Cardiology and Subsequent Complications of Diabetes mellitus Diakonissenkrankenhaus Mannheim Germany Academic Teaching Hospital Clinical Medicine Mannheim University Heidelberg K.Amendt@diakonissen.de Das Bild kann nicht angezeigt werden. Dieser Computer verfügt möglicherweise über zu wenig Arbeitsspeicher, um das Bild zu öffnen, oder das Bild ist beschädigt. Starten Sie den Computer neu, und öffnen Sie dann erneut die Datei. Wenn weiterhin das rote x angezeigt wird, müssen Sie das Bild möglicherweise löschen und dann ern

Balloon: acute: injury/trauma: dissektion occlusion, residual-stenosis chronic: re-stenosis, re-occlusion coagulation, aggregation: thrombus chronic: trauma (COF) re-stenosis, re-occlusion Artery: acute: recoil (Ca++) spasm chronic: re-stenosis, re-occlusion stent-fracture progression of disease

Multiple Stent delivery system: MSDS multi-LOC (VascuFlex Multi-LOC ®)

Components MSDS Sheath Stents Working length Guide-wire radial force / stentdesigns Newton (N) Treated vessel diameter 13 mm 4, 5, 6, 7, 8 mm 1/stent closed cell designe comparable to standard niJnol stents Individual Stent Length Diameter Radioopaque marker Designe Radial force Design - Stent-Größe DEKRA: CE – marking: 27.05.2015; FIM 17.06.2015 © K. Amendt

Multiple Stent delivery system: MSDS multi-LOC (VascuFlex Multi-LOC ®) Animal experiments (porcine) acute chronic (3 w surv.) Standard „long“ nitinol stent •  feasibility •  exact anatomically controlled release •  no stent loss Clincal experiences post CE- marking: •  no stent fracture •  superior patency vs standard nitinol stent •  reproducibility of animal results •  nearly no neg. influence on biomechanical properties of arteries •  stabilized lumen, also in severely

CHnicalTrials.gov A service of the U.S. National Institutes of Health Example: “Heart attack" AND "Los Angeles" Search Advanced Search Help Studies by Topic Glossary Find Studies About Clinical Studies Submit Studies Resources About This Site Home > Find Studies > Search Results 3 studies found for: locomotive Modify this search | How to Use Search Results + Show Display Options cp Down|oad subscribe to RSS □ Include only open studies □ Exclude studies with Unknown status Rank Status Study "All Comers" Post Market Clinical Follow-up (PMCF) With Multi-LOC forflOw MMiting Outcomes...

LOCOMOTIVE registry: to assess safety and efficacy of the multi-LOC peripheral stents system to treat de novo and restenotic lesions non randomized prospective, multi-center registry common femoral to distal popliteal artery, all comers registry: RCC 2-5, Fontaine II- IV flow limiting dissections and recoil after POBA and DCB-dilatation. „whenever stenting is indicated“

Exclusion criteria: Primary endpoint: Additional variables: patients with PAOD: Rutherf.: 2-5, Fontaine: 2-4 stenosis and occlusions of SFA, PA1-3, also re-do lesion length: suitable for release of at least 2 stents with a distance of at least 5mm between 2 stents reference vessel diameter: 4-7mm adequate distal run off: at least 1 vessel to the foot or calf collaterals supplying sufficient flow to the foot also severe calcification, after subintimal PTA, Instent-restenosis Restenosis after DCB 6 month TLR- rate 12 month TLR rate @ 6 and 12 month: walking distance (S1, S2) ABI , CCD:...

LOCOMOTIVE registry: Dr. Hartel, Lippe Detmold Dr. Thalwitzer, „ , „ . Zwickau Prof. Dengler, Bad Friedrichshall Dr. Vogel, Dr. Brado, Heido|horn Prof. Blessing, Karlsbad Prof. Zeller, Bad Krozingen

LOCOMOTIVE registry: 6-mo FU patients: n: 75Patient demographics Patients Age, years Male gender Fontaine I la lib III IV Diabetes mellitus Hypertension Hypercholesteremia Renal insufficiency Dialysis dependent Coronary artery disease Cerebrovascular disease Carotid artery disease History of smoking

Target lesions/p Treated leg, target lesions left right Reference vessel diameter, mm Distal run off 1 2 3 no vessel Lesion location SFAI SFAII SFA III PI P2 P3 TASC II class target lesion A B C D unknown TASC C/D lesions Total lesion length, cm range Diffuse vessel disease Calcification Total occlusion Target lesion total occlusions

Critical limb ischemia No critical limb ischemia

Critical limb ischemia No critical limb ischemia 1 patient: reocclusion after 6 weeks without medication, alkol-disease:mww 2017_01_05

LOCOMOTIVE registry: 6-mo FU patients: n: 75 Clinical outcomes

LOCOMOTIVE registry: 6-mo FU patients: n: 75 Conclusions The first clinical experience @ 6 months suggests that the MSDS strategy is safe and effective in patients with PAOD (RCC 2-5) with femoro-popliteal lesions: Ø  High procedural success rate (100%) to release the individual stent segments also in morphologically challenging lesions. Ø  No stent-loss, no conversion to standard stenting Ø  almost half of the lesion length could be saved from stenting as compared to the “long stent” strategy. Ø  TLR rates in CLI and non-CLI patients of less than 5% @ 6 months. Ø  primary patency rate...