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

NCT03785431 | Unknown DMC

• 1 other identifier: KB/169/2016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI; Cardiovascular Disease; Bioresorbable Scaffold

Keywords

STEMI; cardiovascular disease; bioresorbable scaffold

Outcome Measures

Primary Outcomes (1)

• Procedural success defined as acute angiographic success (residual stenosis <20% and TIMI flow 3) without in-hospital major adverse cardiac events (MACE)

  From time of procedure until the date of discharge from hospital assessed up to 30 days

Secondary Outcomes (4)

• Angiographic success defined as device implantation into target lesion with residual stenosis of < 20% and presence of grade 3 TIMI flow assessed by angiography

  3 years

• Quantitative coronary angiographic measurements including minimum lumen diameter (mm), late lumen loss (mm) evaluated post-procedure at 6, 18 and 36 months

  3 years

• OCT measurements at patient level evaluated post-procedure, at 6, 18 and 36 months.

  3 years

• Quantitative coronary angiographic measurements including diameter stenosis (%) at 6, 18 and 36 months

  3 years

Study Arms (1)

Intervention

EXPERIMENTAL

Patient diagnosed with ST elevation myocardial infarction will undergo bioresorbable stent deployment in culprit lesion.

Device: PCI with Phantom Bioresorbable Scaffold

Interventions

PCI with Phantom Bioresorbable Scaffold DEVICE

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.

Also known as: OCT and NIRS-IVUS Evaluation

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:
• mm by visual estimate for single scaffold implantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

1st Department of Cardiology, Medical University of Warsaw

Warsaw, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Cardiovascular Diseases

Interventions

Percutaneous Coronary Intervention; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Central Study Contacts

Lukasz Koltowski, Adjunct. Prof., MD, PhD

CONTACT

48501418951; lukasz@koltowski.com

Mariusz Tomaniak, MD, PhD

CONTACT

48501418951; mariusz.tomaniak@interia.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Prof., MD, PhD

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: December 24, 2018
• Study Start: June 6, 2017
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2022
• Last Updated: December 24, 2018

Record last verified: 2018-12

Locations

PL (1)