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Bare Metal Bifurcation Stent Clinical Trial in Humans (BRANCH)

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ClinicalTrials.gov Identifier: NCT00607321
Recruitment Status : Completed
First Posted : February 5, 2008
Results First Posted : August 31, 2011
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Coronary Artery Disease
Myocardial Ischemia
Intervention Device: Medtronic Bifurcation Stent System
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Medtronic Bifurcation Stent System
Hide Arm/Group Description Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title Medtronic Bifurcation Stent System
Hide Arm/Group Description Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
60.4  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
8
  15.1%
Male
45
  84.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
Australia 39
New Zealand 14
1.Primary Outcome
Title Number of Participants With Target Vessel Failure (TVF) at 30 Days Post Procedure.
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Receiving Bifurcation Stents
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: Participants
2
2.Secondary Outcome
Title Device Success
Hide Description 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.
Time Frame During index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
ITT included all subjects after a run-in subject at each site.
Arm/Group Title Bifurcation Stent System
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: participants
46
3.Secondary Outcome
Title Number of Participants With Target Vessel Failure (TVF) at 6 Months
Hide Description 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.
Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients receiving bifurcation stent and having evaluable data.
Arm/Group Title Bifurcation Stent System
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
4
4.Secondary Outcome
Title Number of Participants With Target Vessel Failure at 9 Months.
Hide Description 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.
Time Frame 9 month
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects receiving bifurcation stents and having evaluable data
Arm/Group Title Bifurcation Stent System
Hide Arm/Group Description:
Evaluable patients within pre-specified follow up window
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
6
5.Secondary Outcome
Title Number of Participant With Target Vessel Failure at 12 Months
Hide Description 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.
Time Frame 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects receiving bifurcation stents and having evaluable data.
Arm/Group Title Subjects Receiving Bifurcation Stents
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
6
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1. Branch Bifurcation Stent System
Hide Arm/Group Description All subjects enrolled in the BRANCH study
All-Cause Mortality
1. Branch Bifurcation Stent System
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
1. Branch Bifurcation Stent System
Affected / at Risk (%) # Events
Total   23/60 (38.33%)    
Blood and lymphatic system disorders   
Anaemia  1  2/60 (3.33%)  2
Cardiac disorders   
Acute Myocardial Infarction  1  1/60 (1.67%)  1
Angina Pectoris  1  8/60 (13.33%)  9
Bradycardia  1  1/60 (1.67%)  1
Cardiac Arrest  1  1/60 (1.67%)  1
Myocardial Infarction  1  4/60 (6.67%)  4
Ventricular Tachycardia  1  1/60 (1.67%)  1
Eye disorders   
Visual Disturbance  1  1/60 (1.67%)  1
General disorders   
Chest Pain  1  5/60 (8.33%)  6
Non-Cardiac Chest Pain  1  2/60 (3.33%)  2
Injury, poisoning and procedural complications   
Device Malfunction  1  1/60 (1.67%)  1
Wrist Fracture  1  1/60 (1.67%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal Chest Pain  1  1/60 (1.67%)  2
Pain In Jaw  1  1/60 (1.67%)  1
Nervous system disorders   
Syncope Vasovagal  1  1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/60 (1.67%)  1
Hyperventilation  1  1/60 (1.67%)  1
Surgical and medical procedures   
Coronary Revascularisation  1  1/60 (1.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1. Branch Bifurcation Stent System
Affected / at Risk (%) # Events
Total   46/60 (76.67%)    
Cardiac disorders   
Bradycardia  1  5/60 (8.33%)  5
Coronary Artery Dissection  1  8/60 (13.33%)  9
Gastrointestinal disorders   
Nausea  1  4/60 (6.67%)  4
General disorders   
Chest Pain  1  8/60 (13.33%)  10
Musculoskeletal and connective tissue disorders   
Back Pain  1  7/60 (11.67%)  7
Nervous system disorders   
Syncope Vasovagal  1  4/60 (6.67%)  4
Vascular disorders   
Haematoma  1  10/60 (16.67%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: K Bogdanovich
Organization: Medtronic Cardiovascular
EMail: rs.medtroniccardiovascularclinicaltrials@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT00607321    
Other Study ID Numbers: IP088
First Submitted: January 22, 2008
First Posted: February 5, 2008
Results First Submitted: August 1, 2011
Results First Posted: August 31, 2011
Last Update Posted: May 18, 2017