The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000770066
Ethics application status
Approved
Date submitted
15/09/2010
Date registered
15/09/2010
Date last updated
18/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Bifurcation Lesions With The BIOTRONIK Pantera Lux Drug Eluting Balloon
Scientific title
Late lumen loss after treatment of coronary bifurcation lesions with a drug-eluting balloon in patients with symptomatic ischemic heart disease
Secondary ID [1] 252442 0
none
Universal Trial Number (UTN)
Trial acronym
BIOLUX I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with symptomatic ischaemic heart disease due to stenotic bifurcation lesions of de novo native coronary arteries 257954 0
Condition category
Condition code
Cardiovascular 258121 258121 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment of bifurcation lesions with a drug-eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon. The drug-eluting balloon is coated with 3 micrograms of paclitaxel per mm^2 of balloon surface. The balloon is inserted into the femoral artery and advanced into the coronary arteries. Once the target lesion is identified using X-ray and a dye (angiogram), the balloon is advanced to the narrowed portion of the vessel and inflated for about 30 seconds thus releasing the drug (paclitaxel) into the surrounding tissue. The balloon is removed immediately after deflation. Another angiogram is performed to confirm restoration of blood flow. This is a one-off procedure and takes about 45 minutes.
Intervention code [1] 257010 0
Treatment: Devices
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258986 0
Late lumen loss in the side branch as measured by quantitative coronary angiography (QCA)
Timepoint [1] 258986 0
9 months post-procedure
Secondary outcome [1] 265182 0
Acute success (defined as achieving a Thrombolysis In Myocardial Infarction (TIMI) flow >3 in both the main vessel and the side branch as well as <70% stenosis in the side branch as assessed by post-procedure angiogram)
Timepoint [1] 265182 0
Immediately post-procedure
Secondary outcome [2] 265183 0
Composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target vessel revascularisation (TVR) which will be assessed by Angina status as per the Canadian Cardiovascular Society Classification (CCSC), data linkage to patient medical records for all adverse events since previous follow up, all concomitant medications since the previous follow up and any coronary treatment that occurred (e.g. interventional or surgical revascularization) since the previous follow up.
Timepoint [2] 265183 0
1, 6, 9, and 12 months post-procedure
Secondary outcome [3] 265184 0
Clinically driven target lesion revascularisation (TLR) rate which will be assessed by Angina status as per the Canadian Cardiovascular Society Classification (CCSC), data linkage to patient medical records for all adverse events since previous follow up, all concomitant medications since the previous follow up and any coronary treatment that occurred (e.g. interventional or surgical revascularization) since the previous follow up.
Timepoint [3] 265184 0
1, 6, 9 and 12 months post-procedure
Secondary outcome [4] 265185 0
Binary angiographic restenosis as measured by QCA
Timepoint [4] 265185 0
9 months post-procedure

Eligibility
Key inclusion criteria
Patient is an acceptable candidate for percutaneous coronary intervention (PCI) and emergent coronary artery bypass graft (CABG) surgery
Patient has clinical evidence of ischaemic heart disease or a positive functional study
Female patients of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
Patient or patient’s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective investigational site
Patient agrees to comply with all specified follow-up evaluations
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or prasugrel, paclitaxel, evrolimus or structurally related compounds, the delivery matrix Butyryltri-n-hexyl Citrate (BTHC), or a sensitivity to contrast media, which cannot be adequately pre-medicated
Platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3, or a white blood cell (WBC) count < 3,000 cells/mm^3 within 7 days prior to the index procedure
Serum creatine level > 170 micromol/L or creatine clearance <60 ml/min. within 7 days prior to index procedure
Evidence of an acute MI within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having creatine kinase (CK) enzymes > 2X the laboratory upper limit of normal with the presence of an elevated creatine kinase-muscle and brain-type (CK-MB) (any amount above the laboratory upper limit of normal)
Previous stenting anywhere in the target vessel
Percutaneous coronary intervention (PCI) of a non-target vessel within 30 days prior to the procedure that results in any major adverse cardiac events (MACE)
Planned PCI of any vessel within 30 days post-procedure
Planned PCI of the target vessel within 6 months post-procedure
During the index procedure, the target lesion requires treatment with a device other than PTCA or cutting balloon prior to stent placement (including, but not limited to, atherectomy, laser, thrombectomy, etc.)
Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
History of a stroke or transient ischemic attack (TIA) within the prior 6 months
Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
History of bleeding diathesis or coagulopathy or will refuse blood transfusions
Concurrent medical condition with a life expectancy of less than 12 months
Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment postcode(s) [1] 3140 0
3065
Recruitment postcode(s) [2] 3138 0
3168
Recruitment postcode(s) [3] 3871 0
4032
Recruitment postcode(s) [4] 3137 0
5000
Recruitment postcode(s) [5] 3139 0
6160

Funding & Sponsors
Funding source category [1] 257464 0
Commercial sector/Industry
Name [1] 257464 0
BIOTRONIK Australia Pty. Ltd.
Address [1] 257464 0
Suite 2, Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country [1] 257464 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BIOTRONIK Australia Pty. Ltd.
Address
Suite 2, Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 256690 0
None
Name [1] 256690 0
Address [1] 256690 0
Country [1] 256690 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259488 0
Southern Health HREC
Ethics committee address [1] 259488 0
Research Support Unit, Level 4, Main Block, Monash Medical Centre, Clayton VIC 3168
Ethics committee country [1] 259488 0
Australia
Date submitted for ethics approval [1] 259488 0
01/09/2010
Approval date [1] 259488 0
26/11/2010
Ethics approval number [1] 259488 0

Summary
Brief summary
The study is intended to assess the feasibility and safety of the BIOTRONIK drug-eluting balloon Pantera Lux for the treatment of narrowing cardiac arteries where those arteries branch out into side arms. The study will assess both immediate success of this treatment as well as whether those arteries remain open after 9 months.
Trial website
Trial related presentations / publications
Bifurcation treatment with a drug coated balloon for the side branch and DES for the main branch: the BIOLUX-I trial presented at TCT2013 by Stephen Worthley (28/10/2013)
Public notes

Contacts
Principal investigator
Name 31521 0
Prof Stephen Worthley
Address 31521 0
Royal Adelaide Hospital, Cardiovascular Investigation Unit, Level 6, Theatre Block, North Terrace, Adelaide SA 5000
Country 31521 0
Australia
Phone 31521 0
+61 8 8222 2890
Fax 31521 0
Email 31521 0
Stephen.Worthley@adelaide.edu.au
Contact person for public queries
Name 14768 0
Mr Falko Thiele
Address 14768 0
Suite 2, Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country 14768 0
Australia
Phone 14768 0
+61294973700
Fax 14768 0
Email 14768 0
Falko.Thiele@biotronik.com
Contact person for scientific queries
Name 5696 0
Prof Stephen Worthley
Address 5696 0
Royal Adelaide Hospital
Cardiovascular Investigation Unit
Level 6, Theatre Block
North Terrace
Adelaide SA 5000
Country 5696 0
Australia
Phone 5696 0
+61 8 8222 2890
Fax 5696 0
Email 5696 0
Stephen.Worthley@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary