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

NCT03785431 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-12-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2019-06-06
Completion
2022-06-06

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785431 on ClinicalTrials.gov