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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663896
First Posted: August 13, 2012
Last Update Posted: January 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  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 ]

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 ]
  • Consideration of health economics data and resource utilization. [ Time Frame: participants will be followed from their hospital stay until 12 months after ]

Enrollment: 418
Study Start Date: November 2012
Study Completion Date: October 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Single or multi vessel disease

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01663896


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01663896     History of Changes
Other Study ID Numbers: SJM-CVD-0612
First Submitted: August 7, 2012
First Posted: August 13, 2012
Last Update Posted: January 11, 2016
Last Verified: January 2016