Trial Outcomes & Findings for Sprinter Legend Balloon Catheter (NCT NCT00961311)

Results Overview

Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

1-3 days

Results posted on

2011-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Balloon Angioplasty All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sprinter Legend Balloon Catheter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Balloon Angioplasty n=51 Participants All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
Age Continuous	67 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 1-3 days

Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure.

Outcome measures

Outcome measures
Measure	Balloon Angioplasty n=51 Participants All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
Procedural Success	100 Percent of Participants

SECONDARY outcome

Timeframe: 1-3 days

Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.

Outcome measures

Outcome measures
Measure	Balloon Angioplasty n=51 Participants All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
Major Adverse Cardic Events (MACE)	2.0 Percent of Participants

SECONDARY outcome

Timeframe: 1-3 days

Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death.

Outcome measures

Outcome measures
Measure	Balloon Angioplasty n=51 Participants All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
Vessel Perforation (Clinical)	0 Percent of Participants

SECONDARY outcome

Timeframe: 1-3 days

Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow.

Outcome measures

Outcome measures
Measure	Balloon Angioplasty n=51 Participants All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
Device Success	100 Percent of Participants

Adverse Events

Balloon Angioplasty

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Balloon Angioplasty n=51 participants at risk All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
Cardiac disorders Atrial Fibrillation	2.0% 1/51 • Number of events 1 • 1-3 days
Cardiac disorders Pericardial Effusion	2.0% 1/51 • Number of events 1 • 1-3 days
General disorders Vessel Puncture Site Haematoma	2.0% 1/51 • Number of events 1 • 1-3 days
Investigations Cardiac Enzymes Increased	5.9% 3/51 • Number of events 3 • 1-3 days
Renal and urinary disorders Renal Failure	2.0% 1/51 • Number of events 1 • 1-3 days

Other adverse events

Adverse event data not reported

Additional Information

K. Bogdanovich

Medtronic Cardiovascular

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator and or Participating lnstitution may publish the results of work performed in accordance with the Publication Strategy described in the Clinical Investigational Plan; provided, however, that any such publication or presentation shall be at a time determined by Medtronic and shall be provided to Medtronic for review at least 60 days prior to submission or presentation, for a determination by Medtronic of whether Confidential lnformation is disclosed.
Publication restrictions are in place

Restriction type: OTHER