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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01308346




Registration number
NCT01308346
Ethics application status
Date submitted
2/03/2011
Date registered
4/03/2011
Date last updated
7/05/2013

Titles & IDs
Public title
ABSORB PHYSIOLOGY Clinical Investigation
Scientific title
ABSORB PHYSIOLOGY Clinical Investigation: Clinical Evaluation of the Short and Long-Term Effects of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold on Coronary Artery Blood Flow and Physiological Responsiveness
Secondary ID [1] 0 0
10-390
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Treatment: Devices - XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Experimental: Bioresorbable Vascular Scaffold (BVS) - Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)

Active comparator: XIENCE V® or XIENCE PRIME® - XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) or XIENCE PRIME®


Treatment: Devices: Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Bioabsorbable Everolimus Eluting Coronary Stent

Treatment: Devices: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Coronary artery endothelial responsiveness
Timepoint [1] 0 0
Post procedure
Secondary outcome [1] 0 0
Coronary artery cross-sectional compliance and cross-sectional distensibility
Timepoint [1] 0 0
Post procedure
Secondary outcome [2] 0 0
Target artery endothelial shear stress distribution
Timepoint [2] 0 0
Post procedure
Secondary outcome [3] 0 0
Wave intensity patterns in the coronary arteries
Timepoint [3] 0 0
Post procedure
Secondary outcome [4] 0 0
Systolic and diastolic coronary artery impedance
Timepoint [4] 0 0
Post procedure
Secondary outcome [5] 0 0
Clinical device success
Timepoint [5] 0 0
Post procedure
Secondary outcome [6] 0 0
Clinical Procedure Success
Timepoint [6] 0 0
during the hospital stay with a maximum of 7 days post index procedure.
Secondary outcome [7] 0 0
Cardiac Death (CD)
Timepoint [7] 0 0
180 days
Secondary outcome [8] 0 0
Cardiac Death (CD)
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
Cardiac Death (CD)
Timepoint [9] 0 0
2 years
Secondary outcome [10] 0 0
Myocardial Infarction (MI)
Timepoint [10] 0 0
180 days
Secondary outcome [11] 0 0
Myocardial Infarction (MI)
Timepoint [11] 0 0
1 year
Secondary outcome [12] 0 0
Myocardial Infarction (MI)
Timepoint [12] 0 0
2 years
Secondary outcome [13] 0 0
Target Vessel Myocardial Infarction (TV-MI)
Timepoint [13] 0 0
180 days
Secondary outcome [14] 0 0
Target Vessel Myocardial Infarction (TV-MI)
Timepoint [14] 0 0
1 year
Secondary outcome [15] 0 0
Target Vessel Myocardial Infarction (TV-MI)
Timepoint [15] 0 0
2 years
Secondary outcome [16] 0 0
All Death, All MI, All Revascularization (DMR)
Timepoint [16] 0 0
180 days
Secondary outcome [17] 0 0
All Death, All MI, All Revascularization (DMR)
Timepoint [17] 0 0
1 year
Secondary outcome [18] 0 0
All Death, All MI, All Revascularization (DMR)
Timepoint [18] 0 0
2 years
Secondary outcome [19] 0 0
Ischemia-Driven MACE (ID-MACE)
Timepoint [19] 0 0
180 days
Secondary outcome [20] 0 0
Ischemia-Driven MACE (ID-MACE)
Timepoint [20] 0 0
1 year
Secondary outcome [21] 0 0
Ischemia-Driven MACE (ID-MACE)
Timepoint [21] 0 0
2 years
Secondary outcome [22] 0 0
Ischemia-Driven Target Vessel Failure (ID-TVF)
Timepoint [22] 0 0
180 days
Secondary outcome [23] 0 0
Ischemia-Driven Target Vessel Failure (ID-TVF)
Timepoint [23] 0 0
1 year
Secondary outcome [24] 0 0
Ischemia-Driven Target Vessel Failure (ID-TVF)
Timepoint [24] 0 0
2 years
Secondary outcome [25] 0 0
Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Timepoint [25] 0 0
180 days
Secondary outcome [26] 0 0
Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Timepoint [26] 0 0
1 year
Secondary outcome [27] 0 0
Ischemia-Driven Target Vessel Revascularization (ID-TVR)
Timepoint [27] 0 0
2 years
Secondary outcome [28] 0 0
Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
Timepoint [28] 0 0
180 days
Secondary outcome [29] 0 0
Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
Timepoint [29] 0 0
1 year
Secondary outcome [30] 0 0
Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)
Timepoint [30] 0 0
2 years
Secondary outcome [31] 0 0
Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
Timepoint [31] 0 0
180 days
Secondary outcome [32] 0 0
Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
Timepoint [32] 0 0
1 year
Secondary outcome [33] 0 0
Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)
Timepoint [33] 0 0
2 years
Secondary outcome [34] 0 0
Ischemia-Driven Target Lesion Revascularization (ID-TLR)
Timepoint [34] 0 0
180 days
Secondary outcome [35] 0 0
Ischemia-Driven Target Lesion Revascularization (ID-TLR)
Timepoint [35] 0 0
1 year
Secondary outcome [36] 0 0
Ischemia-Driven Target Lesion Revascularization (ID-TLR)
Timepoint [36] 0 0
2 years
Secondary outcome [37] 0 0
Scaffold/Stent thrombosis
Timepoint [37] 0 0
180 days
Secondary outcome [38] 0 0
Scaffold/Stent thrombosis
Timepoint [38] 0 0
1 year
Secondary outcome [39] 0 0
Scaffold/Stent thrombosis
Timepoint [39] 0 0
2 years
Secondary outcome [40] 0 0
Coronary artery endothelial responsiveness
Timepoint [40] 0 0
2 years
Secondary outcome [41] 0 0
Coronary artery cross-sectional compliance and cross-sectional distensibility
Timepoint [41] 0 0
2 years
Secondary outcome [42] 0 0
Target artery endothelial shear stress distribution
Timepoint [42] 0 0
2 years
Secondary outcome [43] 0 0
Wave intensity patterns in the coronary arteries
Timepoint [43] 0 0
2 years
Secondary outcome [44] 0 0
Systolic and diastolic coronary artery impedance
Timepoint [44] 0 0
2 years

Eligibility
Key inclusion criteria
1. Participant must be a male of at least 18 years of age or a female that is post-menopausal and not on hormone replacement therapy.
2. Participant is able to verbally confirm understanding of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative must provide written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
3. Participant must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia with a positive functional study).
4. Participant must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. Participant must agree to undergo all clinical investigation plan-required follow-up visits.
6. Participant must agree not to participate in any other clinical investigation for a period of 2 years following the index procedure. This includes clinical trials of medications and invasive procedures. Only questionnaire-based studies are allowed.

Angiographic

1. A single de novo native coronary artery lesion suitable to be treated by either a BVS or a mDES.
2. Target lesion must be located in a native coronary artery in which the mean proximal and distal vessel diameter of the target lesion (Dmean) fall within the range of = 2.25 mm and = 3.25 mm and the target lesion length measures = 22 mm as assessed by IVUS.
3. Target lesion must be located in the main branch of a major epicardial vessel (i.e., LAD, LCX, or RCA) with a visually estimated diameter stenosis of = 50% and < 100% with a TIMI flow of = 1.
4. Participant must have an additional angiographically smooth (< 40% diameter stenosis) non-target vessel to act as an intra-participant control vessel (self-control vessel). The self-control vessel must be the main branch of a major epicardial vessel (i.e., LAD, LCX, or RCA).
5. Coronary anatomy must be suitable for IVUS, OCT, and pressure and flow wire instrumentation.

General
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant has a known diagnosis of spontaneous acute myocardial infarction (AMI) within 14 days preceding the index procedure.
2. Participant has high-risk acute coronary syndrome (e.g., dynamic ST-T wave change on ECG or recurrent chest pain/nitrate-unresponsive prolonged chest pain at rest within 48 hours prior to the index procedure).
3. Participant has any evidence of myocardial infarct in the territory subtended by the proposed target vessel or self-control vessel.
4. Participant has current unstable arrhythmias.
5. Participant has chronic atrial fibrillation.
6. Participant has a known left ventricular ejection fraction (LVEF) < 40%.
7. Participant has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
8. Participant has previously had CABG or mitral or aortic valve repair/replacement.
9. Participant is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the index procedure.
10. Participant is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
11. Participant has a chronic systemic condition or medication likely to interfere with coronary physiology and/or conduit artery function (e.g., chronic inflammatory condition, chronic renal failure, or chronic obstructive pulmonary disease).
12. Participant has known renal insufficiency.
13. Participant is receiving or scheduled to receive any planned radiotherapy.
14. Participant is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) at the onset of the clinical investigation.
15. Participant has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, anti-platelet medications specified for use in the study (clopidogrel, prasugrel and ticlopidine, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers, or contrast sensitivity that cannot be adequately pre-medicated.
16. Elective surgery is planned within the first 6 months after the index procedure that will require discontinuing aspirin, clopidogrel, prasugrel, or ticlopidine.
17. Participant has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) within 7 days prior to the index procedure.
18. Participant has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
19. Participant has had a cerebrovascular accident/stroke (CVA) or transient ischemic neurological attack (TIA) within the past 6 months.
20. Participant has had a significant gastro-intestinal or significant urinary bleed within the past 6 months.
21. Participant has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
22. Participant has a history of paradoxical exercise-induced vasoconstriction that is consistent with myocardial bridging in the coronary anatomy.
23. Participant has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that in the judgment of the Investigator may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy.
24. Participant is currently participating in another clinical investigation that has not yet reached its primary endpoint.
25. Percutaneous interventions for lesions in the third major epicardial vessel (the one that does not contain the target or the self-control vessel) were performed within 30 days preceding the index procedure or are planned to be done within 6 months following the index procedure.
26. Planned PCI procedures in the target vessel (and/or any of its side branches) or the self-control vessel (and/or any of its side branches) within 2 years following the index procedure.
27. Participant who does not suspend drugs that will influence vaso-function.

Angiographic Exclusion Criteria

1. Target lesion meets any of the following criteria:

1. Left main location;
2. RCA aorto-ostial location (within 10 mm from expected proximal stent/scaffold edge);
3. LAD or LCX ostial location (within 10 mm from expected proximal stent/scaffold edge);
4. Involves a bifurcation with a side branch = 2 mm in diameter, an ostial lesion > 40% stenosed by visual estimation, or a side branch requiring pre-dilatation;
5. Total occlusion (TIMI flow 0) prior to wire crossing;
6. Excessive tortuosity proximal to or within the lesion;
7. Extreme angulation (= 90°) proximal to or within the lesion;
8. Heavy calcification in the lesion;
9. Located in a side branch.
2. Participant has a high probability that a procedure other than pre-dilatation, scaffold/stent implantation, and post-dilatation (if applicable) will be required at the time of index procedure for treatment of the target vessel (e.g., atherectomy, cutting balloon or brachytherapy).
3. The target vessel (and/or any of its side branches) or the self-control vessel (and/or any of its side branches) contains visible thrombus.
4. The target vessel or the self-control vessel has previously been treated by any PCI procedures.
5. A side branch of the target vessel or a side branch of the self-control vessel has received any percutaneous interventions within 30 days prior to the index procedure.
6. Another clinically significant lesion is located in the target vessel (and/or any of its side branches) or the self-control vessel (and/or any of its side branches) that may require PCI treatments within 2 years following the index procedure.
7. Participant has evidence of myocardial bridging in the coronary anatomy during the angiographic evaluation.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Netherlands
State/province [2] 0 0
Rotterdam
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.

To evaluate the following in participants undergoing coronary artery scaffolding/stenting for significant coronary artery disease:

* The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold (BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological responsiveness of the target coronary artery
* The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and physiological responsiveness of the target coronary artery
Trial website
https://clinicaltrials.gov/study/NCT01308346
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian Meredith, Prof, MD
Address 0 0
Monash Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01308346