AngioSculpt® Coronary Bifurcation Study (AGILITY)

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. Identifier: NCT00686647
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : August 10, 2011
Last Update Posted : August 10, 2011
Information provided by:
AngioScore, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischemia Device: AngioSculpt® Scoring Balloon Catheter Device: AngioSculpt Scoring Balloon Catheter Not Applicable

Detailed Description:

Background: Bifurcation lesions, which consist of a narrowing occurring at branch points of coronary arteries, typically involve both the main branch (parent vessel) and an adjacent side branch. These lesions pose a particularly challenging situation for angioplasty procedures due to the difficulty of covering both branches with stents and a higher rate of recurrence (restenosis). A new angioplasty scoring balloon catheter (AngioSculpt®) has recently been approved for the treatment of narrowings in coronary arteries. The AngioSculpt® catheter incorporates a nitinol device that consists of spiral wires that wrap around the balloon catheter. As the balloon inflates, the spiral wires score the lesion allowing the balloon to be more stable (avoid slippage) and may enlarge the narrowed sections of the artery with less pressure or risk of dissection (uncontrolled tearing of the inner lining of the artery wall commonly seen with conventional balloons).

Study Purpose: To demonstrate the safety and efficacy of the AngioSculpt® used in conjunction with coronary stents (implantable wire mesh tubes for scaffolding blocked arteries) for the treatment of coronary artery bifurcation narrowings and to compare these results with the historical outcomes associated with the use of conventional balloons and stents in the treatment of bifurcation lesions.

Study Design: A prospective, multi-center, non-randomized, single-arm study with results compared to a literature search derived historical control for conventional balloon angioplasty (OPC - Objective Performance Criteria). The intent of this study is to enroll and treat 100 patients at 8 U.S. interventional cardiology programs with clinical follow-up planned at 30 days and 9 months following the procedure.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AngioSculpt® Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study
Study Start Date : April 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : January 2011

Intervention Details:
  • Device: AngioSculpt® Scoring Balloon Catheter
    Use of a stent for the main branch of a bifurcation lesion and use of a scoring balloon for the side branch of the same bifurcation lesion
  • Device: AngioSculpt Scoring Balloon Catheter
    Treatment of the side-branch vessel of true bifurcation lesions using the AngioSculpt device

Primary Outcome Measures :
  1. Procedural Success [ Time Frame: 1 day ]
    Defined as less than or equal to 30% diameter stenosis in the main branch and less than or equal to 70% diameter stenosis in the side branch at the conclusion of the procedure (including adjunctive stenting) in the absence of in-hospital major adverse cardiac events (MACE) [cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR]

Secondary Outcome Measures :
  1. Major Adverse Cardiovascular Events [ Time Frame: 30 days ]
    cardiac death, myocardial infarction, or target lesion revascularization

  2. Major Adverse Cardiac Events [ Time Frame: 9 months ]
    cardiac death, myocardial infarction, or target lesion revascularization

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 < 35%
  • Patients refusing or not candidates for emergency coronary artery bypass grafting (CABG)surgery
  • Uncontrolled severe hypertension (systolic BP >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 <10 g/dL
  • Coagulopathy manifested by platelet count <100,000 or International Normalized ratio (INR) >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 < 2.5 mm in diameter
  • Target main branch lesion > 30 mm in length
  • Intended use of a bare metal stent (BMS) in the main branch
  • Target side branch vessel < 2.0 mm in diameter
  • Target side branch lesion > 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

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 identifier (NCT number): NCT00686647

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
AngioScore, Inc.
Principal Investigator: Jeffrey W. Moses, M.D. Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gary Gershony, M.D., Chief Medical Officer, AngioScore, Inc. Identifier: NCT00686647     History of Changes
Other Study ID Numbers: ASC-ST1210
First Posted: May 30, 2008    Key Record Dates
Results First Posted: August 10, 2011
Last Update Posted: August 10, 2011
Last Verified: July 2011

Keywords provided by AngioScore, Inc.:
Coronary Angioplasty
Coronary Stents
Scoring Balloons
Coronary Artery Bifurcation Lesions

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes