Status:
COMPLETED
SPECTACL: SPECTroscopic Assessment of Coronary Lipid
Lead Sponsor:
Infraredx
Conditions:
Angina Pectoris
Angina, Unstable
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 percu...
Detailed Description
Extensive studies conducted over the past 7 years in autopsy specimens have demonstrated that NIR spectroscopy can identify the plaque structures that are suspected to cause the acute coronary artery ...
Eligibility Criteria
Inclusion
- \>=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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00330928
Start Date
January 1 2006
End Date
October 1 2008
Last Update
January 5 2021
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Lahey Clinic
Burlington, Massachusetts, United States, 01805
3
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
4
Columbia University Medical Center
New York, New York, United States, 10032