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Vascular Healing After Implantation of FANTOM Bioresorbable Scaffold in STEMI: A FANTOM STEMI Study (FANTOM STEMI)

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ClinicalTrials.gov Identifier: NCT03785431
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Łukasz Kołtowski, Medical University of Warsaw

Brief Summary:
The study will assess the safety and performance of the Fantom sirolimus eluting bioresorbable vascular scaffold (BVS) in the acute setting of myocardial infarction with unstable lesions and thrombogenic milieu.This is a prospective evaluation of clinical and patient related measures in STEMI patient who undergo urgent primary percutaneous coronary intervention (PCI) with stent implantation. Patients with culprit lesions with 2.5 - 3.5 mm diameter and located in one of the main coronary arteries will be included in the trial and prospectively observed. The study will comprise 20 patients, who will undergo additional evaluation with optical coherence tomography (OCT) and near-infrared spectroscopy/intravascular ultrasound (NIRS/IVUS) at baseline, 6 months, 18-24 months and 36 months. The device will be delivered in sizes 2.5 and 3.0 in diameter / 18 and 24 mm and 3.5 mm x 18 mm in length.

Condition or disease Intervention/treatment Phase
STEMI Cardiovascular Disease Bioresorbable Scaffold Device: PCI with Phantom Bioresorbable Scaffold Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vascular Healing Pattern, Vasoreactivity, and Quality of Life in Patients With ST Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention With Sirolimus Eluting FANTOM Bioresorbable Vascular Scaffold With Long Term Clinical, Near Infrared Spectroscopy and Optical Coherence Tomography Follow-up: A FANTOM STEMI Pilot Study
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 6, 2019
Estimated Study Completion Date : June 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Intervention
Patient diagnosed with ST elevation myocardial infarction will undergo bioresorbable stent deployment in culprit lesion.
Device: PCI with Phantom Bioresorbable Scaffold
Once baseline angiography is performed and all eligibility criteria are met, the patient is included in the study. The target lesion should be crossed with a standard coronary guidewire. Next, the NIRS/IVUS and OCT probe is inserted and a pullback is being performed to evaluate the lesion and vessel morphology. The predilatation with 1:1 non-compliant or semi-compliant balloon is mandatory. Thereafter the scaffold should be inserted and position across the target lesion. Lesions up to 14 mm should be covered with the 18 mm device, for lesions of 15-20 mm a 24 mm device should be used. The scaffold will be deployed with intent to achieve the inner diameter to the reference vessel ration of 1:1 using a single inflation. Post-dilatation using a non-compliant balloon should be performed to achieve complete scaffold apposition and reduce the residual angiographic stenosis below 20%. The final NIRS/IVUS and OCT of the target vessel should be performed.
Other Name: OCT and NIRS-IVUS Evaluation




Primary Outcome Measures :
  1. Procedural success defined as acute angiographic success (residual stenosis <20% and TIMI flow 3) without in-hospital major adverse cardiac events (MACE) [ Time Frame: From time of procedure until the date of discharge from hospital assessed up to 30 days ]

Secondary Outcome Measures :
  1. Angiographic success defined as device implantation into target lesion with residual stenosis of < 20% and presence of grade 3 TIMI flow assessed by angiography [ Time Frame: 3 years ]
  2. Quantitative coronary angiographic measurements including minimum lumen diameter (mm), late lumen loss (mm) evaluated post-procedure at 6, 18 and 36 months [ Time Frame: 3 years ]
  3. OCT measurements at patient level evaluated post-procedure, at 6, 18 and 36 months. [ Time Frame: 3 years ]
  4. Quantitative coronary angiographic measurements including diameter stenosis (%) at 6, 18 and 36 months [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Electrocardiographic confirmation of acute coronary syndrome with ST segment elevation (according to the 2012 European Society of Cardiology guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation) or high-risk non-ST segment elevation patients in whom urgent reperfusion strategy is applied.

    • Symptom onset to balloon inflation time <12 hours
    • Age >18 years
    • The patient's written informed consent has been obtained prior to the procedure.
    • Each lesion must meet all the following baseline criteria (prior to pre-dilation):

      • De novo lesion in a native coronary artery.
      • Visually estimated stenosis of at least 50%.
      • Visually estimated RVD ≥2.5 mm and ≤3.5 mm (RVD defined as mean of proximal and distal RVD)
      • Lesion length:

        • 20 mm by visual estimate for single scaffold implantation
    • Each lesion must meet all the following criteria after pre-dilatation:

      • Target vessel reference diameter ≤3.5 mm by visual assessment.
      • Lesion length:

        • 20 mm by visual estimate for single scaffold implantation

Exclusion Criteria:

Candidates will be excluded from the trial if ANY of the following exclusion criteria are met:

A. Clinical

  • Cardiogenic shock or pulmonary edema
  • Known hypersensitivity or contraindication to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparins, abciximab, everolimus, or polylactide
  • Hypersensitivity to contrast agents
  • Concomitant diseases resulting in significantly worse long-term prognosis
  • Acute and chronic inflammatory conditions
  • Lack of patient consent
  • Acute mechanical complications of myocardial infarction
  • Known pregnancy at time of randomization. Female who is breastfeeding at time of randomization.
  • Fibrinolysis prior to PCI.
  • Active bleeding or coagulopathy or patient at chronic anticoagulation therapy
  • Life expectancy less then 12 months.
  • Patient has a scheduled surgery or another contraindications that may preclude 12-month dual antiplatelet therapy.
  • Subject participating in an other trial B. Angiographic
  • Significant left main coronary artery stenosis
  • Multivessel disease requiring coronary artery bypass grafting (MVD scheduled for percutaneous treatment is not considered as an exclusion criteria).
  • Culprit lesion location within a true bifurcation with a large side branch (vessel lumen diameter >2.0 mm)
  • Presence of massive calcifications seen within the vessel contour or identified using intracoronary imaging techniques
  • Lesion within a vein bypass graft
  • Lesions located within 3 mm from vessel origin
  • Target lesion located within previously stented region
  • Anatomic location and lesion morphology precluding an optimal effect of percutaneous coronary intervention (PCI) or imaging by OCT in the opinion of the investigator
  • Excessive proximal tortuosity
  • Vessel diameter <2.5 mm and > 3.5 mm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785431


Contacts
Contact: Lukasz Koltowski, Adjunct. Prof., MD, PhD 48501418951 lukasz@koltowski.com
Contact: Mariusz Tomaniak, MD, PhD 48501418951 mariusz.tomaniak@interia.pl

Locations
Poland
1st Department of Cardiology, Medical University of Warsaw Recruiting
Warsaw, Poland, 02-097
Contact: Lukasz Koltowski, MD, PhD       lukasz@koltowski.com   
Contact: Mariusz Tomaniak, MD       mariusz.tomaniak@interia.pl   
Principal Investigator: Lukasz Koltowski, MD, PhD         
Sub-Investigator: Janusz Kochman, MD, PhD         
Sub-Investigator: Mariusz Tomaniak, MD, PhD         
Sub-Investigator: Jakub Maksym, MD         
Sponsors and Collaborators
Medical University of Warsaw

Responsible Party: Łukasz Kołtowski, Adjunct Prof., MD, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03785431     History of Changes
Other Study ID Numbers: KB/169/2016
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Łukasz Kołtowski, Medical University of Warsaw:
STEMI
cardiovascular disease
bioresorbable scaffold

Additional relevant MeSH terms:
Cardiovascular Diseases
ST Elevation Myocardial Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Vascular Diseases