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Trial registered on ANZCTR


Registration number
ACTRN12607000578404
Ethics application status
Approved
Date submitted
1/11/2007
Date registered
9/11/2007
Date last updated
9/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Coronary Intervention Using the CardioMind Coronary Stent System for the treatment of stenotic lesions in small diameter native coronary arteries
Scientific title
A prospective, randomized, multicenter study to evaluate the safety, efficacy and performance of the CardioMind Coronary Stent Systems for treatment of stenotic lesions in small diameter native coronary arteries.
Universal Trial Number (UTN)
Trial acronym
CARE II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 2523 0
Condition category
Condition code
Cardiovascular 2619 2619 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will randomize 230 patients with de novo lesions in native coronary arteries with a reference diameter of 2.0 – 2.75 mm. The 3 treatment arms include the CardioMind sirolimus-eluting stent, the CardioMind bare metal stent, and the Medtronic Micro-Driver bare metal stent. Clinical follow-up will occur at 30 days, 8, 12 and 24 months. Telephone follow-up will occur at 6 months and years 3-5. Data will be compared among treatment groups.
Intervention code [1] 2252 0
Treatment: Devices
Comparator / control treatment
Medtronic Micro-Driver bare metal stent for the same duration of the intervention
Control group
Active

Outcomes
Primary outcome [1] 3530 0
In-stent late lumen loss by quantitative coronary angiography (QCA)
Timepoint [1] 3530 0
8 months after treatment]
Secondary outcome [1] 5902 0
Major adverse cardiac events
Timepoint [1] 5902 0
Hospital discharge, 30 days, 8, 12, 24 months after treatment
Secondary outcome [2] 5903 0
Major vascular complications
Timepoint [2] 5903 0
hospital discharge
Secondary outcome [3] 5904 0
Stent thrombosis
Timepoint [3] 5904 0
Within 30 days after treatment
Secondary outcome [4] 5905 0
Device, Lesion, Procedure Success
Timepoint [4] 5905 0
Hospital discharge
Secondary outcome [5] 5906 0
Clinically driven target lesion revascularization, target vessel revascularization or target vessel failure
Timepoint [5] 5906 0
30 days, 8, 12, 24 months after treatment
Secondary outcome [6] 5907 0
In-stent and in-segment binary restenosis, minimum lumen diameter and % diameter stenosis
Timepoint [6] 5907 0
8 months after treatment
Secondary outcome [7] 5908 0
In-segment late lumen loss
Timepoint [7] 5908 0
8 months after treatment
Secondary outcome [8] 5909 0
2D & 3D Intravascular Ultrasound (sub-set of patients)
Timepoint [8] 5909 0
8 months after treatment

Eligibility
Key inclusion criteria
Suitable candidate for percutaneous coronary intervention (PCI) in a symptomatic native coronary vessel with a reference diameter of 2.0 – 2.75 mm and lesion length < 20 mm. Treatment of one non-target lesion in a separate epicardial vessel is allowed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Need for treatment of a second lesion in the target vessel 30 days before or after the index procedure, excessive calcification or tortuosity, presence of thrombus or Thrombolysis in Myocardial Infarction (TIMI) flow < 2, concomitant health conditions (renal insufficiency, recent stroke, myocardial infarction (MI) or gastrointestinal (GI) bleeding), pregnant, unable to comply with antiplatelet therapy, ostial lesions, low coronary reserve.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After angiographic criteria is confirmed, the investigator will open a sequentially numbered envelope containing a randomization assignment card for that subject.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be block-randomized by clinical site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 313 0
3065
Recruitment postcode(s) [2] 314 0
3168
Recruitment postcode(s) [3] 315 0
4032
Recruitment postcode(s) [4] 316 0
5000
Recruitment postcode(s) [5] 317 0
3000
Recruitment outside Australia
Country [1] 642 0
Belgium
State/province [1] 642 0
Brazil
Germany
Switzerland
New Zealand
Spain
Singapore
Malaysia

Funding & Sponsors
Funding source category [1] 2763 0
Commercial sector/Industry
Name [1] 2763 0
CardioMind
Country [1] 2763 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CardioMind
Address
257 Humboldt Court
Sunnyvale, CA 94089
Country
United States of America
Secondary sponsor category [1] 2496 0
None
Name [1] 2496 0
Address [1] 2496 0
Country [1] 2496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4684 0
St. Vincent's Health
Ethics committee address [1] 4684 0
140 Williams St.
Melbourne VIC 3000
PO Box 4301PP
Melbourne VIC 3001
Australia
Ethics committee country [1] 4684 0
Australia
Date submitted for ethics approval [1] 4684 0
Approval date [1] 4684 0
18/10/2007
Ethics approval number [1] 4684 0
MIR:AZR:0431861

Summary
Brief summary
The study will enroll 230 patients in a randomized evaluation of a new stent delivery system developed for use in small coronary arteries. The study device is designed with a low profile, maneuverable delivery system to reach small, distal lesions. This study is designed to show that the new stents are safe and effective when compared to the comparator, commercially-available stent. Follow-up will occur at 30 days, 6, 8, and 12 month intervals for the first year, then annually for the next four years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28159 0
Address 28159 0
Country 28159 0
Phone 28159 0
Fax 28159 0
Email 28159 0
Contact person for public queries
Name 11316 0
Marlys Kaluzniak
Address 11316 0
257 Humboldt Court
Sunnyvale, CA 94089
Country 11316 0
United States of America
Phone 11316 0
+1 805-990-1646
Fax 11316 0
+1 408 329 5252
Email 11316 0
[email protected]
Contact person for scientific queries
Name 2244 0
Marlys Kaluzniak
Address 2244 0
257 Humboldt Court
Sunnyvale, CA 94089
Country 2244 0
United States of America
Phone 2244 0
+1 805-990-1646
Fax 2244 0
+1 408 329 5252
Email 2244 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.