ABSORB PHYSIOLOGY Clinical Investigation

NCT01308346 | Terminated

• 1 other identifier: 10-390
• Study Type: interventional
• Target: 1
• Locations: 4 countries
• Sites: 6

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

Conditions

Coronary Artery Disease

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

Outcome Measures

Primary Outcomes (1)

• Coronary artery endothelial responsiveness

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

  Post procedure

Secondary Outcomes (44)

• Coronary artery cross-sectional compliance and cross-sectional distensibility

  Post procedure

• Target artery endothelial shear stress distribution

  Post procedure

• Wave intensity patterns in the coronary arteries

  Post procedure

• Systolic and diastolic coronary artery impedance

  Post procedure

• Clinical device success

  Post procedure

Study Arms (2)

Bioresorbable Vascular Scaffold (BVS)

EXPERIMENTAL

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

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

XIENCE V® or XIENCE PRIME®

ACTIVE COMPARATOR

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) or XIENCE PRIME®

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

Interventions

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

Bioabsorbable Everolimus Eluting Coronary Stent

Bioresorbable Vascular Scaffold (BVS)

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) DEVICE

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

XIENCE V® or XIENCE PRIME®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Monash Medical Centre

Melbourne, 3168, Australia

Location

Queen Elizabeth

Hong Kong, China

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

National Heart Centre Singapore

Singapore, 168752, Singapore

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ian Meredith, Prof, MD

  Monash Medical Center

  PRINCIPAL INVESTIGATOR

• James Cameron, Prof, MD

  Monash Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

NL (1); SG (1); AU (3); CN (1)