Trial Outcomes & Findings for AngioSculpt® Coronary Bifurcation Study (NCT NCT00686647)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

93 participants

Primary outcome timeframe

1 day

Results posted on

2011-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	AngioSculpt Device
Overall Study STARTED	93
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AngioSculpt Device
Overall Study Lost to Follow-up	1
Overall Study Death	1

Baseline Characteristics

AngioSculpt® Coronary Bifurcation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AngioSculpt Device n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=93 Participants
Age, Categorical >=65 years	36 Participants n=93 Participants
Age Continuous	61.54 years STANDARD_DEVIATION 11.6 • n=93 Participants
Sex: Female, Male Female	26 Participants n=93 Participants
Sex: Female, Male Male	67 Participants n=93 Participants
Region of Enrollment United States	93 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 day

Population: intention to treat

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

Outcome measures

Outcome measures
Measure	Overall Study n=93 Participants
Procedural Success	91.4 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: intention to treat

cardiac death, myocardial infarction, or target lesion revascularization

Outcome measures

Outcome measures
Measure	Overall Study n=93 Participants
Major Adverse Cardiovascular Events	1.1 percentage of particpants

SECONDARY outcome

Timeframe: 9 months

cardiac death, myocardial infarction, or target lesion revascularization

Outcome measures

Outcome measures
Measure	Overall Study n=93 Participants
Major Adverse Cardiac Events	5.4 percentage of participants

Adverse Events

AngioSculpt Device

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AngioSculpt Device n=93 participants at risk
Skin and subcutaneous tissue disorders cellulitis	2.2% 2/93 • Number of events 2
Cardiac disorders Death	1.1% 1/93 • Number of events 1

Other adverse events

Other adverse events
Measure	AngioSculpt Device n=93 participants at risk
Cardiac disorders Chest pain	7.5% 7/93 • Number of events 7

Additional Information

Gary Gershony, MD/ Chief Medical Officer

AngioScore

Phone: 510-933-7900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER