AGILITY: AngioSculpt® Coronary Bifurcation Study

• Sponsor: AngioScore, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00686647
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Duration (Months): 33
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Myocardial Ischemia	Device: AngioSculpt® Scoring Balloon Catheter; Device: AngioSculpt Scoring Balloon Catheter	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: AngioSculpt® Scoring Balloon Catheter Multi-Center Coronary Bifurcation Study
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Outcome Measures

Primary Outcome Measures

1. Procedural Success [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]

Secondary Outcome Measures

1. Major Adverse Cardiovascular Events [30 days]

   cardiac death, myocardial infarction, or target lesion revascularization

2. Major Adverse Cardiac Events [9 months]

   cardiac death, myocardial infarction, or target lesion revascularization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00686647
• Other Study ID Numbers: ASC-ST1210
• First Posted: May 30, 2008
• Last Update Posted: Aug 10, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Coronary Angioplasty; Coronary Stents; Scoring Balloons; Coronary Artery Bifurcation Lesions
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Ischemia

Study Results

Participant Flow

Arm/Group Title	AngioSculpt Device
Arm/Group Description
Period Title: Overall Study
STARTED	93
COMPLETED	91
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	AngioSculpt Device
Arm/Group Description
Overall Participants	93
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	57 61.3%
>=65 years	36 38.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.54 (11.6)
Sex: Female, Male (Count of Participants)
Female	26 28%
Male	67 72%
Region of Enrollment (participants) [Number]
United States	93 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Overall Study
Arm/Group Description
Measure Participants	93
Number [percentage of participants]	91.4 98.3%

2. Secondary Outcome

Title	Major Adverse Cardiovascular Events
Description	cardiac death, myocardial infarction, or target lesion revascularization
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	AngioSculpt Device
Arm/Group Description
Measure Participants	93
Number [percentage of particpants]	1.1

3. Secondary Outcome

Title	Major Adverse Cardiac Events
Description	cardiac death, myocardial infarction, or target lesion revascularization
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AngioSculpt Device
Arm/Group Description
Measure Participants	93
Number [percentage of participants]	5.4 5.8%

Adverse Events

Arm/Group Title	AngioSculpt Device
Arm/Group Description
All Cause Mortality
	AngioSculpt Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	AngioSculpt Device
	Affected / at Risk (%)	# Events
Total	2/93 (2.2%)
Cardiac disorders
Death	1/93 (1.1%)	1
Skin and subcutaneous tissue disorders
cellulitis	2/93 (2.2%)	2
Other (Not Including Serious) Adverse Events
	AngioSculpt Device
	Affected / at Risk (%)	# Events
Total	7/93 (7.5%)
Cardiac disorders
Chest pain	7/93 (7.5%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Prior to submission, the Sponsor, Institution, and Site Investigators will review and authorize the publication. A review period of 15 days for Presentational materials and abstracts; and 30 days for manuscripts is required for the Sponsor's review. Sponsor review does not include editorial privileges but can protect proprietary information and correct errors in data reporting or analysis if the Investigator agrees that there is an error.