Trial Outcomes & Findings for Bare Metal Bifurcation Stent Clinical Trial in Humans (NCT NCT00607321)

Last Updated: 2017-05-18

Results Overview

TVF was reported if any of the following events occurred: Recurrent MI in territory not clearly attributed to a vessel other than the target lesion; Cardiac death not clearly due to a non-target vessel endpoint or Clinically driven target revascularization.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

30 days

Results posted on

2017-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Medtronic Bifurcation Stent System Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bare Metal Bifurcation Stent Clinical Trial in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medtronic Bifurcation Stent System n=53 Participants Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
Age, Continuous	60.4 years STANDARD_DEVIATION 11.74 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment Australia	39 participants n=5 Participants
Region of Enrollment New Zealand	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Subjects Receiving Bifurcation Stents n=52 Participants
Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.	2 Participants

SECONDARY outcome

Timeframe: During index procedure

Population: ITT included all subjects after a run-in subject at each site.

Device success is reported as Historical-standard definition: attainment of \<50% residual stenosis of all target lesion/s using only the assigned device and any adjunct stents as specified in the Investigational Plan.

Outcome measures

Outcome measures
Measure	Subjects Receiving Bifurcation Stents n=53 Participants
Device Success	46 participants

SECONDARY outcome

Timeframe: 6 month

Population: Includes all patients receiving bifurcation stent and having evaluable data.

Outcome measures

Outcome measures
Measure	Subjects Receiving Bifurcation Stents n=47 Participants
Number of Participants With Target Vessel Failure (TVF) at 6 Months	4 participants

SECONDARY outcome

Timeframe: 9 month

Population: Includes all subjects receiving bifurcation stents and having evaluable data

Outcome measures

Outcome measures
Measure	Subjects Receiving Bifurcation Stents n=47 Participants
Number of Participants With Target Vessel Failure at 9 Months.	6 participants

SECONDARY outcome

Timeframe: 12 month

Population: Includes all subjects receiving bifurcation stents and having evaluable data.

Outcome measures

Outcome measures
Measure	Subjects Receiving Bifurcation Stents n=47 Participants
Number of Participant With Target Vessel Failure at 12 Months	6 participants

Adverse Events

1. Branch Bifurcation Stent System

Serious events: 23 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1. Branch Bifurcation Stent System n=60 participants at risk All subjects enrolled in the BRANCH study
Blood and lymphatic system disorders Anaemia	3.3% 2/60 • Number of events 2 • 12 months
Cardiac disorders Acute Myocardial Infarction	1.7% 1/60 • Number of events 1 • 12 months
Cardiac disorders Angina Pectoris	13.3% 8/60 • Number of events 9 • 12 months
Cardiac disorders Bradycardia	1.7% 1/60 • Number of events 1 • 12 months
Cardiac disorders Cardiac Arrest	1.7% 1/60 • Number of events 1 • 12 months
Cardiac disorders Myocardial Infarction	6.7% 4/60 • Number of events 4 • 12 months
Cardiac disorders Ventricular Tachycardia	1.7% 1/60 • Number of events 1 • 12 months
Eye disorders Visual Disturbance	1.7% 1/60 • Number of events 1 • 12 months
General disorders Chest Pain	8.3% 5/60 • Number of events 6 • 12 months
General disorders Non-Cardiac Chest Pain	3.3% 2/60 • Number of events 2 • 12 months
Injury, poisoning and procedural complications Device Malfunction	1.7% 1/60 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Wrist Fracture	1.7% 1/60 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	1.7% 1/60 • Number of events 2 • 12 months
Musculoskeletal and connective tissue disorders Pain In Jaw	1.7% 1/60 • Number of events 1 • 12 months
Nervous system disorders Syncope Vasovagal	1.7% 1/60 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Asthma	1.7% 1/60 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Hyperventilation	1.7% 1/60 • Number of events 1 • 12 months
Surgical and medical procedures Coronary Revascularisation	1.7% 1/60 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	1. Branch Bifurcation Stent System n=60 participants at risk All subjects enrolled in the BRANCH study
Cardiac disorders Bradycardia	8.3% 5/60 • Number of events 5 • 12 months
Cardiac disorders Coronary Artery Dissection	13.3% 8/60 • Number of events 9 • 12 months
Gastrointestinal disorders Nausea	6.7% 4/60 • Number of events 4 • 12 months
General disorders Chest Pain	13.3% 8/60 • Number of events 10 • 12 months
Musculoskeletal and connective tissue disorders Back Pain	11.7% 7/60 • Number of events 7 • 12 months
Nervous system disorders Syncope Vasovagal	6.7% 4/60 • Number of events 4 • 12 months
Vascular disorders Haematoma	16.7% 10/60 • Number of events 11 • 12 months

Additional Information

K Bogdanovich

Medtronic Cardiovascular

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60