Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention (ILUMIEN I)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01663896
First received: August 7, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

To define and evaluate OCT stent guidance parameters through prospective data collection in PCI procedures of de novo lesions.


Condition
Single or Multi Vessel Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Identify OCT peri-procedural guidance parameter(s) for stent implantation that relates with patient outcomes in the hospital, at 30 days, and 12 months post intervention. [ Time Frame: participants will be followed from their hospital stay until 12 months after ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation/relationship of OCT parameters, as defined by OCT volumetric analysis, on pre and post intervention FFR values. [ Time Frame: participants will be followed from their hospital stay until 12 months after ] [ Designated as safety issue: No ]
  • Consideration of health economics data and resource utilization. [ Time Frame: participants will be followed from their hospital stay until 12 months after ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: November 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single or multi vessel disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Elective or ad hoc PCI, stable angina, acute coronary syndrome

Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Patient provides signed written informed consent before any study-specific procedure.
  3. De novo coronary artery disease in target vessel.
  4. Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated, with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
  5. Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and NSTEMI).
  6. Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery.
  7. Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects with an FFR ≤ 0.80 in target vessel.

Exclusion Criteria:

  1. Subjects with STEMI, emergent PCI, or in cardiogenic shock.
  2. Subjects with target left main lesion.
  3. Subjects with restenosis or stent thrombosis in the target vessel.
  4. Planned use of bare metal stent.
  5. Known renal insufficiency (examples being but not limited to eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).
  6. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
  7. Extreme angulation (> 90°) or excessive tortuosity (> two 45° angles) proximal to or within the target lesion.
  8. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
  9. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
  10. Currently participating in another clinical study that interferes with study results.
  11. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
  12. Life expectancy less than 1 year.
  13. Potential for non-compliance to protocol requirements and follow-up.
  14. Planned or prior heart transplantation or listed for heart transplant.
  15. Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663896

  Show 36 Study Locations
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01663896     History of Changes
Other Study ID Numbers: SJM-CVD-0612
Study First Received: August 7, 2012
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board
Japan: Institutional Review Board
Hong Kong: Ethics Committee

ClinicalTrials.gov processed this record on April 16, 2014