N/A
N=93
AngioSculpt® Coronary Bifurcation Study
Coronary Artery Disease · Myocardial Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT00686647 ↗Enrolled (actual)
93
Serious AEs
2.2%
Results posted
Aug 2011
Primary outcome: Primary: Procedural Success — 91.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AngioSculpt® Scoring Balloon Catheter (Device); AngioSculpt Scoring Balloon Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AngioScore, Inc.
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedural Success |
91.4 | — |
| SECONDARY Major Adverse Cardiovascular Events |
1.1 | — |
| SECONDARY Major Adverse Cardiac Events |
5.4 | — |
Summary
The purpose of this study is to evaluate a new angioplasty catheter, AngioSculpt® for the treatment of bifurcation lesions (blockages occurring at branch points) in coronary arteries.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age and able to give informed consent.
- Patients with significant (> 50% diameter stenosis) native coronary artery disease involving a bifurcation and the ostium of the side branch vessel (Medina class (x, x, 1)) including stable or unstable angina and silent ischemia.
- Patients with lesions suitable for percutaneous coronary intervention (PCI).
Exclusion Criteria
- Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
- Additional planned coronary interventions for a non-target lesion within 9 months of the study procedure.
- Left ventricular ejection fraction 180 mm Hg or diastolic BP >110 mm Hg)
- Patients who are not candidates for chronic treatment with aspirin or Clopidogrel/Ticlopidine
- Severe renal failure with creatinine >2.0 mg/dL
- Untreated pre-procedural hemoglobin 2.0 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
- Women who are known or suspected to be pregnant
- Patients in cardiogenic shock
- Acute myocardial infarction (MI) within the past 72 hours, and/or elevated CPK (and abnormal Troponin-I) at the time of enrollment
- Patients with a life expectancy of less than 1 year
- Target main branch vessel 30 mm in length
- Intended use of a bare metal stent (BMS) in the main branch
- Target side branch vessel 15 mm in length
- Target bifurcation angle > 90º (distal angle)
- Totally obstructed target coronary arteries (TIMI 0 or 1 flow)
- Target bifurcation lesion within a previously placed stent (i.e. in-stent restenosis (ISR))
- Target bifurcation lesion within a surgical conduit (e.g. saphenous vein or internal mammary)
- Target lesion demonstrating severe dissection prior to planned deployment of the AngioSculpt device
- Unprotected Left Main diameter stenosis ≥ 50%
- Visible thrombus (by angiography) at target lesion site
- Coronary spasm in the absence of a significant stenosis
- Patients who are concurrently participating in an investigational study when such participation could confound the treatment or outcomes of this study
Data sourced from ClinicalTrials.gov (NCT00686647). 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.