The trial is taking place at:
S

Szpital Uniwersytecki W Krakowie | Oddzial Kliniczny Kardiologii Elektrokardiologii Interwencyjnej Nadcisnienia Tetniczego

Veeva-enabled site

Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold (FANTOM II)

R

REVA Medical

Status

Active, not recruiting

Conditions

Coronary Artery Disease

Treatments

Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Study type

Interventional

Funder types

Industry

Identifiers

NCT02539966
HCT6200

Details and patient eligibility

About

The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient has evidence of myocardial ischemia or a positive functional study
  • Target lesion has a visually estimated stenosis of ≥50% and <100%
  • Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.5mm and ≤ 3.5mm
  • Lesion length ≤ 20 mm by visual estimate (N/A for Cohort C)
  • Baseline TIMI flow ≥ 2

Exclusion criteria

  • The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN.
  • Patient has a left ventricular ejection fraction < 40%
  • Patient has unprotected left main coronary disease with ≥50% stenosis
  • The target vessel is totally occluded (TIMI Flow 0 or 1)
  • Target lesion involves a bifurcation (a lesion with a side branch ≥ 1.5 mm in diameter containing a ≥ 50% stenosis).
  • Target lesion is located within a bypass graft
  • Target lesion has possible or definite thrombus

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

220 participants in 3 patient groups

Cohort A
Experimental group
Description:
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
Treatment:
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Cohort B
Experimental group
Description:
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
Treatment:
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Cohort C
Experimental group
Description:
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
Treatment:
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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