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Coronary Artery DiseaseNCT01308346

ABSORB PHYSIOLOGY Clinical Investigation

A study testing Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) and XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in people with Coronary Artery Disease, run by Abbott Medical Devices at 6 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) and XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
6 sitesin 4 countries
Study dates
Nov 2011to Apr 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Participant must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia with a positive functional study).
  • Participant must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • Participant must agree to undergo all clinical investigation plan-required follow-up visits.
  • 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.
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  • Angiographic Inclusion Criteria:
  • A single de novo native coronary artery lesion suitable to be treated by either a BVS or a mDES.
  • 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.
  • 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.
  • 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).
  • Coronary anatomy must be suitable for IVUS, OCT, and pressure and flow wire instrumentation.
  • General Exclusion Criteria:
  • Participant has a known diagnosis of spontaneous acute myocardial infarction (AMI) within 14 days preceding the index procedure.
  • 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).
  • Participant has any evidence of myocardial infarct in the territory subtended by the proposed target vessel or self-control vessel.
  • Participant has current unstable arrhythmias.
  • Participant has chronic atrial fibrillation.
  • Participant has a known left ventricular ejection fraction (LVEF) < 40%.
  • Participant has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
  • Participant has previously had CABG or mitral or aortic valve repair/replacement.
  • Participant is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the index procedure.
  • Participant is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
  • 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).
  • Participant has known renal insufficiency.
  • Participant is receiving or scheduled to receive any planned radiotherapy.
  • Participant is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) at the onset of the clinical investigation.
  • 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.
  • Elective surgery is planned within the first 6 months after the index procedure that will require discontinuing aspirin, clopidogrel, prasugrel, or ticlopidine.
  • 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.
  • Participant has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Participant has had a cerebrovascular accident/stroke (CVA) or transient ischemic neurological attack (TIA) within the past 6 months.
  • Participant has had a significant gastro-intestinal or significant urinary bleed within the past 6 months.
  • Participant has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
  • Participant has a history of paradoxical exercise-induced vasoconstriction that is consistent with myocardial bridging in the coronary anatomy.
  • 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.
  • Participant is currently participating in another clinical investigation that has not yet reached its primary endpoint.
  • 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.
  • 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.
  • Participant who does not suspend drugs that will influence vaso-function.
  • Angiographic Exclusion Criteria
  • Target lesion meets any of the following criteria:
  • Left main location;
  • RCA aorto-ostial location (within 10 mm from expected proximal stent/scaffold edge);
  • LAD or LCX ostial location (within 10 mm from expected proximal stent/scaffold edge);
  • 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;
  • Total occlusion (TIMI flow 0) prior to wire crossing;
  • Excessive tortuosity proximal to or within the lesion;
  • Extreme angulation (≥ 90°) proximal to or within the lesion;
  • Heavy calcification in the lesion;
  • Located in a side branch.
  • 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).
  • 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.
  • The target vessel or the self-control vessel has previously been treated by any PCI procedures.
  • 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.
  • 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.
  • Participant has evidence of myocardial bridging in the coronary anatomy during the angiographic evaluation.

Who cannot join

None listed.

Trial locations and contacts

6 sites in 4 countries.

6 sites in 4 countries

Australia3 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Austin Health

    Heidelberg, Victoria, 3084

  • Monash Medical Centre

    Melbourne, 3168

Other trials in Australia

China1 site

  • Queen Elizabeth

    Hong Kong

Other trials in China

Netherlands1 site

  • Maasstad Ziekenhuis

    Rotterdam

Other trials in Netherlands

Singapore1 site

  • National Heart Centre Singapore

    Singapore, 168752

Other trials in Singapore

About this study

Official 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

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
Read the detailed description
  • Prospective, randomized, single-blinded, multi-center clinical investigation comparing target vessel and non-intervened, self-control vessel within participants and between participants undergoing BVS or mDES deployment for the treatment of a single de novo native coronary artery lesion
  • The investigation will include two arms:
  • Study device (BVS) arm: Abbott Vascular's Everolimus-Eluting Bioresorbable Vascular Scaffold
  • Control device (mDES) arm: Abbott Vascular's Everolimus-Eluting XIENCE V or XIENCE PRIME
Being tested
Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS), XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
Keywords
Bioabsorbable, Coronary Stent, Everolimus, drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, myocardial ischemia, coronary artery stenosis
Medical subject headings
Coronary Artery Disease, Coronary Restenosis, Myocardial Ischemia, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)Device

    Bioabsorbable Everolimus Eluting Coronary Stent

  • XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)Device

    XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Study groups in NCT01308346
Study groupRoleWhat they receive
Bioresorbable Vascular Scaffold (BVS)ExperimentalBioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Receives: Device: Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
XIENCE V® or XIENCE PRIME®Active comparatorXIENCE V® Everolimus Eluting Coronary Stent System (EECSS) or XIENCE PRIME®
Receives: Device: XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary artery endothelial responsiveness

    Change of vessel diameter by 1) pacing, 2) hand-grip and 3) acetylcholine injection

    Measured: Post procedure

Secondary outcomes (44)

  1. Coronary artery cross-sectional compliance and cross-sectional distensibility

    Cross-sectional compliance is defined as change in area per unit change in pressure; cross-sectional distensibility is defined as compliance/diastolic cross-sectional area.

    Measured: Post procedure

  2. Target artery endothelial shear stress distribution

    Wall Shear Stress (WSS) will be determined from flow velocity and blood viscosity

    Measured: Post procedure

  3. Wave intensity patterns in the coronary arteries

    Looking at re-distribution of energy in the blood flow along the coronary artery.

    Measured: Post procedure

  4. Systolic and diastolic coronary artery impedance

    Measured: Post procedure

  5. Clinical device success

    Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system.

    Measured: Post procedure

  6. Clinical Procedure Success

    Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system without the occurrence of ischemia driven major adverse cardiac event (MACE).

    Measured: during the hospital stay with a maximum of 7 days post index procedure.

  7. Cardiac Death (CD)

    Measured: 180 days

  8. Cardiac Death (CD)

    Measured: 1 year

  9. Cardiac Death (CD)

    Measured: 2 years

  10. Myocardial Infarction (MI)

    Measured: 180 days

  11. Myocardial Infarction (MI)

    Measured: 1 year

  12. Myocardial Infarction (MI)

    Measured: 2 years

  13. Target Vessel Myocardial Infarction (TV-MI)

    Measured: 180 days

  14. Target Vessel Myocardial Infarction (TV-MI)

    Measured: 1 year

  15. Target Vessel Myocardial Infarction (TV-MI)

    Measured: 2 years

  16. All Death, All MI, All Revascularization (DMR)

    Measured: 180 days

  17. All Death, All MI, All Revascularization (DMR)

    Measured: 1 year

  18. All Death, All MI, All Revascularization (DMR)

    Measured: 2 years

  19. Ischemia-Driven MACE (ID-MACE)

    Measured: 180 days

  20. Ischemia-Driven MACE (ID-MACE)

    Measured: 1 year

  21. Ischemia-Driven MACE (ID-MACE)

    Measured: 2 years

  22. Ischemia-Driven Target Vessel Failure (ID-TVF)

    Measured: 180 days

  23. Ischemia-Driven Target Vessel Failure (ID-TVF)

    Measured: 1 year

  24. Ischemia-Driven Target Vessel Failure (ID-TVF)

    Measured: 2 years

  25. Ischemia-Driven Target Vessel Revascularization (ID-TVR)

    Measured: 180 days

  26. Ischemia-Driven Target Vessel Revascularization (ID-TVR)

    Measured: 1 year

  27. Ischemia-Driven Target Vessel Revascularization (ID-TVR)

    Measured: 2 years

  28. Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)

    Measured: 180 days

  29. Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)

    Measured: 1 year

  30. Ischemia-Driven Self-Control Vessel Revascularization (ID-SCVR)

    Measured: 2 years

  31. Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)

    Measured: 180 days

  32. Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)

    Measured: 1 year

  33. Ischemia-Driven Non-Target, Non-Self-Control Vessel Revascularization (ID-NTNSCVR)

    Measured: 2 years

  34. Ischemia-Driven Target Lesion Revascularization (ID-TLR)

    Measured: 180 days

  35. Ischemia-Driven Target Lesion Revascularization (ID-TLR)

    Measured: 1 year

  36. Ischemia-Driven Target Lesion Revascularization (ID-TLR)

    Measured: 2 years

  37. Scaffold/Stent thrombosis

    Measured: 180 days

  38. Scaffold/Stent thrombosis

    Measured: 1 year

  39. Scaffold/Stent thrombosis

    Measured: 2 years

  40. Coronary artery endothelial responsiveness

    Change of vessel diameter by 1) pacing, 2) hand-grip and 3) acetylcholine injection

    Measured: 2 years

  41. Coronary artery cross-sectional compliance and cross-sectional distensibility

    Cross-sectional compliance is defined as change in area per unit change in pressure; cross-sectional distensibility is defined as compliance/diastolic cross-sectional area.

    Measured: 2 years

  42. Target artery endothelial shear stress distribution

    Wall Shear Stress (WSS) will be determined from flow velocity and blood viscosity

    Measured: 2 years

  43. Wave intensity patterns in the coronary arteries

    Looking at re-distribution of energy in the blood flow along the coronary artery.

    Measured: 2 years

  44. Systolic and diastolic coronary artery impedance

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionApr 2013
  4. Study completionApr 2013

Why it stopped: Due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01308346
Sponsor's protocol ID
10-390
Status last verified
May 2013
First submitted
2 Mar 2011
Last updated
7 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) and XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) in people with Coronary Artery Disease, run by Abbott Medical Devices at 6 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 57 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia, China, Netherlands, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary artery endothelial responsiveness (time frame: Post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.

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ABSORB PHYSIOLOGY Clinical Investigation (NCT01308346) | AzTrials