AngioSculpt® Coronary Bifurcation Study (AGILITY)

This study has been completed.
Sponsor:
Information provided by:
AngioScore, Inc.
ClinicalTrials.gov Identifier:
NCT00686647
First received: May 28, 2008
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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 Intervention
Coronary Artery Disease
Myocardial Ischemia
Device: AngioSculpt® Scoring Balloon Catheter
Device: AngioSculpt Scoring Balloon Catheter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AngioSculpt® Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study

Resource links provided by NLM:


Further study details as provided by AngioScore, Inc.:

Primary Outcome Measures:
  • Procedural Success [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    cardiac death, myocardial infarction, or target lesion revascularization

  • Major Adverse Cardiac Events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    cardiac death, myocardial infarction, or target lesion revascularization


Enrollment: 93
Study Start Date: April 2008
Study Completion Date: January 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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
    Other Name: AngioSculpt® Scoring Balloon Catheter
    Device: AngioSculpt Scoring Balloon Catheter
    Treatment of the side-branch vessel of true bifurcation lesions using the AngioSculpt device
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686647

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

No publications provided by AngioScore, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gary Gershony, M.D., Chief Medical Officer, AngioScore, Inc.
ClinicalTrials.gov Identifier: NCT00686647     History of Changes
Other Study ID Numbers: ASC-ST1210
Study First Received: May 28, 2008
Results First Received: June 17, 2011
Last Updated: July 14, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014