AzTrials
AzTrials

Coronary Artery DiseaseAGILITYNCT00686647

AngioSculpt® Coronary Bifurcation Study

A study testing AngioSculpt® Scoring Balloon Catheter and AngioSculpt Scoring Balloon Catheter in people with Coronary Artery Disease and Myocardial Ischemia, run by AngioScore, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Myocardial Ischemia
What is being tested?
AngioSculpt® Scoring Balloon Catheter and AngioSculpt Scoring Balloon Catheter
Type of treatment
Medical device
How many people
93 participants
Where
1 siteUnited States
Study dates
Apr 2008to Jan 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
AngioSculpt® Scoring Balloon Catheter, AngioSculpt Scoring Balloon Catheter
Keywords
Coronary Angioplasty, Coronary Stents, Scoring Balloons, Coronary Artery Bifurcation Lesions
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AngioSculpt® Scoring Balloon CatheterDevice

    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

  • AngioSculpt Scoring Balloon CatheterDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: 1 day

Secondary outcomes (2)

  1. Major Adverse Cardiovascular Events

    cardiac death, myocardial infarction, or target lesion revascularization

    Measured: 30 days

  2. Major Adverse Cardiac Events

    cardiac death, myocardial infarction, or target lesion revascularization

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionApr 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00686647
Sponsor's protocol ID
ASC-ST1210
Acronym
AGILITY
Status last verified
Jul 2011
First submitted
28 May 2008
Last updated
10 Aug 2011
Data monitoring committee
No

Publications

  • 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.

    PubMed 22927100

Questions about this trial

What is this clinical trial studying?

A study testing AngioSculpt® Scoring Balloon Catheter and AngioSculpt Scoring Balloon Catheter in people with Coronary Artery Disease and Myocardial Ischemia, run by AngioScore, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural Success (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00686647, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
AngioSculpt® Coronary Bifurcation Study (NCT00686647) | AzTrials