Phase 3
Completed N=106
SPECTACL: SPECTroscopic Assessment of Coronary Lipid
Angina pectoris · Angina, Unstable · Myocardial Infarction
Source: ClinicalTrials.gov NCT00330928 ↗
Enrolled (actual)
106
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Spectral Similarity — 83 percent similarity
Summary
The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention (PCI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spectral Similarity |
83 | — |
| SECONDARY Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes |
— | — |
| SECONDARY Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics |
— | — |
| SECONDARY Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment |
0; 0; 0; 0 | — |
| SECONDARY Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals. |
— | — |
Eligibility Criteria
Inclusion Criteria
- >=18yrs and undergoing elective or non-emergent PCI of a de novo native coronary artery lesion
- Treatment plan (at time of consent and at time of intervention) must be to perform an intervention on no more than 2 lesions, where one is the culprit lesion and the other lesion requires revascularization at the discretion of the treating physician.
- Target lesion should have "low-risk" characteristics(defined by angiography)
- Subject must be able to read, understand and sign an approved informed consent form and follow protocol
- Female subjects of child bearing potential must have a negative serum pregnancy test prior to enrollment
Exclusion Criteria
- Evidence of Clinical instability in the 6 hours before the procedure, or at any time during the procedure (72 hours stable post-STEMI)
- Angiographically Unsuitable Coronary and/or Lesion Morphology in the culprit vessel.
- A contraindication to anticoagulation or increased risk of bleeding.
- Clinically significant abnormal laboratory findings
- Presence of a drug eluting stent in the artery for experimental study prior to NIR measurement, unless all struts are covered by endothelium as documented by IVUS
- Elective PCI on or through bypass grafts or LIMA grafts
- Allergy or intolerance to aspirin or clopidogrel
- Planned use of laser ablation, rotational ablation, brachytherapy, or atherectomy device
- Enrollment or participation in any other medication trial within the previous 30 days
- Current enrollment participation or enrolled in another clinical trial
- Any other factor that the investigator feels would put the patient at increased risk if participating in the protocol
Data sourced from ClinicalTrials.gov (NCT00330928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.