AngioSculpt® Coronary Bifurcation Study (AGILITY)

July 14, 2011 updated by: AngioScore, Inc.

AngioSculpt® Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events
Time Frame: 30 days
cardiac death, myocardial infarction, or target lesion revascularization
30 days
Major Adverse Cardiac Events
Time Frame: 9 months
cardiac death, myocardial infarction, or target lesion revascularization
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AngioScore, Inc.

Investigators

  • Principal Investigator: Jeffrey W. Moses, M.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimate)

May 30, 2008

Study Record Updates

Last Update Posted (Estimate)

August 10, 2011

Last Update Submitted That Met QC Criteria

July 14, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC-ST1210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Ischemia

Clinical Trials on AngioSculpt® Scoring Balloon Catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe