NCT00686647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 10, 2011

Completed
Last Updated

August 10, 2011

Status Verified

July 1, 2011

Enrollment Period

2 years

First QC Date

May 28, 2008

Results QC Date

June 17, 2011

Last Update Submit

July 14, 2011

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Keywords

Coronary AngioplastyCoronary StentsScoring BalloonsCoronary Artery Bifurcation Lesions

Outcome Measures

Primary Outcomes (1)

  • 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) \[cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR\]

    1 day

Secondary Outcomes (2)

  • Major Adverse Cardiovascular Events

    30 days

  • Major Adverse Cardiac Events

    9 months

Interventions

AngioSculpt Scoring Balloon CatheterDEVICE

Treatment of the side-branch vessel of true bifurcation lesions using the AngioSculpt device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 22927100DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Gary Gershony, MD/ Chief Medical Officer
Organization
AngioScore
gary@angioscore.com
510-933-7900

Study Officials

  • Jeffrey W. Moses, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2008

First Posted

May 30, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Study Completion

January 1, 2011

Last Updated

August 10, 2011

Results First Posted

August 10, 2011

Record last verified: 2011-07

Locations

US(1)