Slide 1: Carotid Artery Endovascular Reconstruction Using Micronet-Covered Stents
TCT 2022 Featured Research TCT Template Carotid Artery Endovascular Title 30 pt Bold Arial Reconstruction Using Micronet-Covered Stents in Patients with Symptoms or Signs of Cerebral Ischemia John Doe, MD Piotr Musialek, Subtitle 25 pt Arial Bold Italics MD DPhil for CGuard OPTIMA Investigators Jagi
Slide 2: CGuard OPTIMA Trial Investigators
CGuard CGuard OPTIMA Trial INVESTIGATORS OPTIMA Piotr Musialek, MD DPhil S. Tomasz Kowalczyk, MD Laura Capoccia, MD PhD Jaroslaw Miszczuk, MD PhD C. Alejandro Alvarez, MD Oleg Krestyaninov, MD PhD Adam Mazurek, MD PhD Magdalena Knapik, MD Lukasz Tekieli, MD PhD Mariusz Trystula, MD PhD Wladyslaw Dab
Slide 3: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Abbott Vascular, InspireMD Consulting Fees/Ho
Slide 4: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 5: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 6: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 7: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 8: CEA, The Gold Standard
CEA, The Gold Standard ”CEA… by removing the plaque removes plaque-related problems” Faculty disclosure information can be found on the app NB. The MicroNet-Covered stent is currently NOT available in the US outiside the FDA-IDE Trial
Slide 9: The Gold Standard… How GOLD?
The ”Gold Standard”… How GOLD ? M, 54 y CEA M, 54 y CEA Asx LICA P Musialek @ TCT 2022
Slide 10: The Gold Standard… How GOLD?
The ”Gold Standard”… How GOLD ? M, 54 y CEA Asx LICA Peri-Procedural Stroke mRS 4 @ 90d P Musialek @ TCT 2022
Slide 11: The Gold Standard… How GOLD?
The ”Gold Standard”… How GOLD ? M, 54 y W, 61 y CEA CEA Asx RICA Asx LICA Peri-Procedural Stroke Stroke 5 days post CEA mRS 4 @ 90d mRS 3 @ 90d P Musialek @ TCT 2022
Slide 12: The Gold Standard… How GOLD?
M, 69 y CEA The ”Gold Standard”… How GOLD ? Severe Calcium S-LICA S-LICA P Musialek @ TCT 2022
Slide 13: The Gold Standard… How GOLD?
M, 69 y CEA The ”Gold Standard”… How GOLD ? Severe Calcium LICA S restenosis S-LICA Symptomatic Restenosis 14-mo post CEA P Musialek @ TCT 2022
Slide 14: The Gold Standard… How GOLD?
M, 69 y CEA The ”Gold Standard”… How GOLD ? Severe NB. MicroNet-Covered Calcium Stent –Treated RICA OK LICA S restenosis S-LICA Symptomatic Restenosis 14-mo post CEA P Musialek @ TCT 2022
Slide 15: The Gold Standard… How GOLD?
M, 69 y CEA The ”Gold Standard”… How GOLD ? Severe NB. MicroNet-Covered Calcium Stent –Treated RICA OK LICA S restenosis S-LICA Symptomatic Restenosis 14-mo post CEA → Resolved with a MicroNet-Covered Stent P Musialek @ TCT 2022
Slide 16: The Gold Standard… How GOLD?
M, 67 y The ”Gold Standard”… How GOLD ? CEA Crescendo TIAs Faculty disclosure information can be found on the app post Discharge P Musialek @ TCT 2022
Slide 17: The Gold Standard… How GOLD?
M, 67 y The ”Gold Standard”… How GOLD ? CEA Crescendo TIAs Faculty disclosure information can be found on the app post Discharge P Musialek @ TCT 2022
Slide 18: The Gold Standard… How GOLD?
M, 67 y The ”Gold Standard”… How GOLD ? CEA Crescendo TIAs Faculty disclosure information can be found on the app post Discharge P Musialek @ TCT 2022
Slide 19: The Gold Standard… How GOLD?
M, 67 y The ”Gold Standard”… How GOLD ? CEA Crescendo TIAs Faculty disclosure information can be found on the app post Discharge P Musialek @ TCT 2022
Slide 20: The Gold Standard… How GOLD?
M, 67 y The ”Gold Standard”… How GOLD ? CEA Crescendo TIAs Faculty disclosure information can be found on the app post Discharge → Resolved with a MicroNet-Covered Stent
Slide 21: The Gold Standard… How GOLD?
W, 59 y CEA The ”Gold Standard”… How GOLD ? Duplex 30-d post-CEA Duplex 30-d post-CEA (no symptoms) P Musialek @ TCT 2022
Slide 22: The Gold Standard… How GOLD?
W, 59 y The ”Gold Standard”… How GOLD ? CEA Duplex 30-d post-CEA Duplex 30-d post-CEA (no symptoms) (movie) → Resolved with a MicroNet-Covered Stent
Slide 23: CEA Result: FINE √
CEA Result: FINE √ P Musialek @ TCT 2022
Slide 24: CEA Result: FINE √ … Really?
CEA Result: FINE √ … Really? … Really??? ≈2:1 P Musialek @ TCT 2022
Slide 25: CEA Result: FINE √ … Really?
CEA Result: FINE √ … Really? … Really??? Slowered ulceration Flow in the ’Broadend’ Segment + ≈2:1 Ulceration ”pocket” Increased ? Thrombogenicity P Musialek @ TCT 2022
Slide 26: An optimal result
The ”Gold Standard”… How GOLD ? ”an optimal result” (no death/stroke/MI) 1. loss of sensation 2. recurrernt skin injury when shaving… Faculty disclosure information can be found on the app no way to resolve
Slide 27: An optimal result
The ”Gold Standard”… How GOLD ? ”an optimal result” (no death/stroke/MI) Faculty disclosure information can be found on the app Vocal fold paralysis
Slide 28: WHERE exactly was the problem?
WHERE exactly was the problem? Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 29: Failure to Eliminate the Plaque
Failure to Eliminate the Plaque with 1st Gen. Carotid Stents (Open-cell and Closed-cell) Plaque prolapse was strongly associated with ischemic stroke by 30 days Faculty disclosure information can be found on the app Kotsugi et al. JACC Intv 2017;10:824-31
Slide 30: Failure to Eliminate the Plaque
Failure to Eliminate the Plaque with 1st Gen. Carotid Stents (Open-cell and Closed-cell) Plaque prolapse was strongly associated with ischemic stroke by 30 days Kotsugi et al. JACC Intv 2017;10:824-31
Slide 31: MicroNet-Covered Stent
MicroNet -Covered Stent Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 32: Hypothesis
CGuard Hypothesis OPTIMA MicroNet-Covered Stent CAS Enables Safe Plaque Prolapse-Free and Residual Stenosis-Free endovascular reconstruction of the diseased Extracranial carotid artery in consecutive patients with symptoms or signs Facultyof cerebral disclosure ischemic information injury can be fou
Slide 33: Methods: IIS
CGuard Methods: IIS OPTIMA • Multi-centric • Multi-specialty ( IC, VS, A/VM, IR/INR ) • Muli-national • All-Comer Patients with Symptoms or Signs of cerebral injury, no age or other limits • Classic lesion severity criteria ( 50% / 80% ) • EPD recommended • Vascular access by Operator choice • Study
Slide 34: Power
CGuard Power CGuard OPTIMA Trial NCT04234854 OPTIMA • Power calculation based on meta-analyzed IVUS large-scale studies of Plaque Prolapse in First-Generation (Single-layered) carotid stents by M Kotsugi et al. and T Okazaki et al. (n=494 stents, Precise - 224, Wallstent - 236, Protege - 34, PP inci
Slide 35: Study Population
CGuard OPTIMA Study Population Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 36: Study Population
CGuard OPTIMA Study Population Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 37: Study Population
CGuard OPTIMA Study Population Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 38: Baseline Characteristics of Lesions
CGuard Baseline Characteristics of Lesions OPTIMA Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 39: Baseline Characteristics of Lesions
CGuard Baseline Characteristics of Lesions OPTIMA Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 40: Baseline Characteristics of Lesions
CGuard Baseline Characteristics of Lesions OPTIMA Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 41: Procedure Characteristics
CGuard OPTIMA Procedure Characteristics TF 337 ( 95.7 %) Technical success 100% TCR 13 ( 3.7 %) Procedural success 99.7% TR 2 ( 0.6 %) Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 42: M, 52y, Right Hemisph. Stroke 5 days before
M, 52y, Right Hemisph. Stroke 5 days before RICA Thr 9 x 30 mm Faculty disclosure CGuard OPTIMA information can be found on the app Trial NCT04234854 Trans-Femoral MoMa Flow Reversal + MicroNet-Covered Stent P Musialek @ TCT 2022
Slide 43: M, 52y, Right Hemisph. Stroke 5 days before
M, 52y, Right Hemisph. Stroke 5 days before RICA Thr 9 x 30 mm Faculty disclosure information can be found on the app Trans-Femoral MoMa Flow Reversal + MicroNet-Covered Stent P Musialek @ TCT 2022
Slide 44: M, 64y, Progressive Tandem Stenosis, Asymptomatic Cerebral Infarct
M, 64y, Progressive Tandem Stenosis, Asymptomatic Cerebral Infarct LICA 10 x 60mm CGuard OPTIMA Trial NCT04234854 Trans-Femoral MoMa Flow Reversal + MicroNet-Covered Stent P Musialek @ TCT 2022
Slide 45: M, 64y, Progressive Tandem Stenosis, Asymptomatic Cerebral Infarct
M, 64y, Progressive Tandem Stenosis, Asymptomatic Cerebral Infarct LICA 10 x 60mm Trans-Femoral MoMa Flow Reversal + MicroNet-Covered Stent P Musialek @ TCT 2022
Slide 46: M, 56y, L hemisp Stroke 10 days before, Severe iliac disease
M, 56y, L hemisp Stroke 10 days before, Severe iliac disease LICA 8 x 30mm CGuard OPTIMA Trial NCT04234854 Trans-Carotid MoMa Flow Reversal + MicroNet-Covered Stent P Musialek @ TCT 2022
Slide 47: M, 56y, L hemisp Stroke 10 days before, Severe iliac disease
M, 56y, L hemisp Stroke 10 days before, Severe iliac disease LICA 8 x 30mm Trans-Carotid MoMa Flow Reversal + MicroNet-Covered Stent P Musialek @ TCT 2022
Slide 48: M, 71y, h/o larynx RadioTx, Leriche, 2 recent R hemisp Strokes
M, 71y, h/o larynx RadioTx, Leriche, 2 recent R hemisp Strokes RICA 7.0 x 20 mm CGuard OPTIMA Trial NCT04234854 Trans-Radial MicroNet-Covered Stent CAS / Filter-Protected P Musialek @ TCT 2022
Slide 49: M, 71y, h/o larynx RadioTx, Leriche, 2 recent R hemisp Strokes
M, 71y, h/o larynx RadioTx, Leriche, 2 recent R hemisp Strokes RICA 7.0 x 20 mm Trans-Radial MicroNet-Covered Stent CAS / Filter-Protected P Musialek @ TCT 2022
Slide 50: IVUS Results
CGuard OPTIMA IVUS Results Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 51: Malapposition was very rare (0.11% frames)
Malapposition was very rare (0.11% frames) Calcium Crushed Calcium Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 52: MicroNet-Covered Stent
MicroNet-Covered Stent Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 53: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 54: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 55: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 56: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 57: Faculty disclosure information can be found on the app
Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 58: A Great Majority of Severely Calcific Lesions Showed No Malapposition
A Great Majority of Severely Calcific Lesions Showed No Malapposition CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 59: Duplex Ultrasound Outcomes at 30-days
CGuard Duplex Ultrasound Outcomes at 30-days OPTIMA Faculty disclosure information can be found on the app P Musialek @ TCT 2022
Slide 60: Clinical Outcomes by 30-days
CGuard OPTIMA Clinical Outcomes by 30-days Faculty disclosure information can be found on the app CGurad OPTIMA Trial P Musialek @ TCT 2022
Slide 61: Conclusions
CGuard Conclusions CGuard OPTIMA Trial NCT04234854 OPTIMA • TOTAL elimination of CAS-associated Plaque Prolase with the routine MicroNet-covered 2nd generation carotid stent stent use in high-risk lesions (clinical symptoms or A/S infarct) OPtimal sequestration of high-risk carotid lesions with effe
Slide 62: Conclusions
CGuard Conclusions CGuard OPTIMA Trial NCT04234854 OPTIMA • TOTAL elimination of CAS-associated Plaque Prolase with the routine MicroNet-covered 2nd generation carotid stent stent use in high-risk lesions (clinical symptoms or A/S infarct) • OPTIMAL endovascular reconstruction (mean residual Area St
Slide 63: Conclusions
CGuard Conclusions CGuard OPTIMA Trial NCT04234854 OPTIMA • TOTAL elimination of CAS-associated Plaque Prolase with the routine MicroNet-covered 2nd generation carotid stent stent use in high-risk lesions (clinical symptoms or A/S infarct) • OPTIMAL endovascular reconstruction (mean residual Area St
Slide 64: Conclusions
CGuard Conclusions CGuard OPTIMA Trial NCT04234854 OPTIMA • TOTAL elimination of CAS-associated Plaque Prolase with the routine MicroNet-covered 2nd generation carotid stent stent use in high-risk lesions (clinical symptoms or A/S infarct) • OPTIMAL endovascular reconstruction (mean residual Area St
Slide 65: Conclusions
CGuard Conclusions CGuard OPTIMA Trial NCT04234854 OPTIMA • TOTAL elimination of CAS-associated Plaque Prolase with the routine MicroNet-covered 2nd generation carotid stent stent use in high-risk lesions (clinical symptoms or A/S infarct) • OPTIMAL endovascular reconstruction (mean residual Area St