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AngioSculpt® Coronary Bifurcation Study (AGILITY)

Primary Purpose

Coronary Artery Disease, Myocardial Ischemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AngioSculpt® Scoring Balloon Catheter
AngioSculpt Scoring Balloon Catheter
Sponsored by
AngioScore, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Angioplasty, Coronary Stents, Scoring Balloons, Coronary Artery Bifurcation Lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Outcomes

Primary Outcome Measures

Procedural Success
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

Major Adverse Cardiovascular Events
cardiac death, myocardial infarction, or target lesion revascularization
Major Adverse Cardiac Events
cardiac death, myocardial infarction, or target lesion revascularization

Full Information

First Posted
May 28, 2008
Last Updated
July 14, 2011
Sponsor
AngioScore, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00686647
Brief Title
AngioSculpt® Coronary Bifurcation Study
Acronym
AGILITY
Official Title
AngioSculpt® Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AngioScore, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Ischemia
Keywords
Coronary Angioplasty, Coronary Stents, Scoring Balloons, Coronary Artery Bifurcation Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
AngioSculpt® Scoring Balloon Catheter
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
AngioSculpt Scoring Balloon Catheter
Intervention Description
Treatment of the side-branch vessel of true bifurcation lesions using the AngioSculpt device
Primary Outcome Measure Information:
Title
Procedural Success
Description
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]
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events
Description
cardiac death, myocardial infarction, or target lesion revascularization
Time Frame
30 days
Title
Major Adverse Cardiac Events
Description
cardiac death, myocardial infarction, or target lesion revascularization
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey W. Moses, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22927100
Citation
Weisz G, Metzger DC, Liberman HA, O'Shaughnessy CD, Douglas JS Jr, Turco MA, Mehran R, Gershony G, Leon MB, Moses JW. A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch: final results of the AGILITY trial. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):352-9. doi: 10.1002/ccd.24630. Epub 2013 Mar 9.
Results Reference
derived

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AngioSculpt® Coronary Bifurcation Study

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