ABSORB III Randomized Controlled Trial (RCT)

NCT ID: NCT01751906

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2008 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2020-10-31

Brief Summary

The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

Detailed Description

ABSORB III RCT:

A. Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

B. Powered Secondary Objectives:

1. Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.

The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III.

The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm.

2. Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement.

All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

Conditions

Coronary Artery Disease; Coronary Artery Stenosis; Coronary Disease; Coronary Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Absorb BVS

Subjects receiving Absorb BVS

Group Type: EXPERIMENTAL

Absorb BVS

Intervention Type: DEVICE

• Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
• The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.

Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

XIENCE

Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition

Group Type: ACTIVE_COMPARATOR

XIENCE

Intervention Type: DEVICE

Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).

• Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
• Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
• For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices

To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Interventions

Absorb BVS

• Scaffold diameters: 2.5, 3.0 and 3.5 mm
• Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
• The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.

Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Intervention Type: DEVICE

XIENCE

Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).

• Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
• Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
• For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices

To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject must be at least 18 years of age.

2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.

3. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.

4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.

5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.

6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.

7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

1. One or two de novo target lesions:

1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.

2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.

3. The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.

2. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed %DS of ≥ 50% and < 100% with a TIMI flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve, stress test), unstable angina or post-infarct angina.

1. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.

2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

Exclusion Criteria

1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure.

2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.

3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.

4. Subject had an acute myocardial infarction (AMI; STEMI or NSTEMI) within 72 hours of the index procedure and both CK and CK-MB have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.

5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

6. Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:

1. Subject requires coumadin or any other agent for chronic oral anticoagulation.

2. Subject is likely to become hemodynamically unstable due to their arrhythmia.

3. Subject has poor survival prognosis due to their arrhythmia.

7. Subject has a left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method, including but not limited to echocardiography, MRI, Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.

8. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.

9. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure

10. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.

11. At the time of screening, the subject has a malignancy that is not in remission.

12. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.

13. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.

14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).

15. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.

16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.

17. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening.

18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.

19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g. aneurysm, arteriovenous malformation, etc.).

20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.

21. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause.

22. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. This includes completion of Patient Reported Outcome instruments.

23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

24. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

1. Residual %DS is a maximum < 40% (per visual estimation), ≤ 20% is strongly recommended.

2. TIMI Grade-3 flow (per visual estimation).

3. No angiographic complications (e.g. distal embolization, side branch closure).

4. No dissections NHLBI grade D-F.

5. No chest pain lasting > 5 minutes.

6. No ST depression or elevation lasting > 5 minutes.

2. Lesion is located in left main.

3. Aorto-ostial RCA lesion (within 3 mm of the ostium).

4. Lesion located within 3 mm of the origin of the LAD or LCX.

5. Lesion involving a bifurcation with a:

1. side branch ≥ 2 mm in diameter, or

2. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or

3. side branch requiring dilatation

6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:

1. Extreme angulation (≥ 90°) proximal to or within the target lesion.

2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.

3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, subject must be excluded if calcium arc in the vessel prior to the lesion or within the lesion is ≥ 180°.

7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT.

8. Lesion or vessel involves a myocardial bridge.

9. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS or XIENCE would need to cross the stent to reach the target lesion.

10. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.

11. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen G Ellis, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Cleveland OH

Dean J Kereiakes, MD

Role: PRINCIPAL_INVESTIGATOR

The Christ Hospital, Cincinnati, OH

Gregg W Stone, MD

Role: STUDY_CHAIR

Columbia University Medical Center, New York, NY

Jennifer McMeans Jones

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

Baptist Medical Center Princeton

Birmingham, Alabama, United States

University of Alabama Hospital

Birmingham, Alabama, United States

Thomas Hospital

Fairhope, Alabama, United States

Baptist Medical Center South

Montgomery, Alabama, United States

Chandler Regional Medical Center

Gilbert, Arizona, United States

Banner Heart Hospital

Mesa, Arizona, United States

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

Scottsdale Healthcare

Scottsdale, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

John Muir Medical Center - Concord Campus

Concord, California, United States

Washington Hospital

Fremont, California, United States

Scripps Green Hospital

La Jolla, California, United States

Scripps Memorial Hospital

La Jolla, California, United States

Good Samaritan Hospital

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Sutter Central Valley Hospitals dba Memorial Medical Center

Modesto, California, United States

Mercy General Hospital

Sacramento, California, United States

UC Davis Medical Center

Sacramento, California, United States

Sutter Medical Center

Sacramento, California, United States

Sharp Memorial Hospital

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Santa Barbara Cottage Hospital

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Stanford Hospital and Clinics

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Little Company Of Mary Hospital

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UCH-Memorial Health Systems

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Medical Center of the Rockies

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Yale-New Haven Hospital

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Baptist Medical Center - Downtown

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MediQuest Research Group Inc at Munroe Regional Medical Center

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Florida Hospital

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Bay County Health Systems

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Baptist Hospital

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Tallahassee Memorial Hospital

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Florida Hospital Pepin Heart Institute

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St. Vincent Heart Center of Indiana

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Mercy Medical

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The University of Kansas Hospital and Medical Center

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University of Kentucky Medical Center

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Jewish Hospital

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Eastern Maine Medical Center

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MedStar Washington Hospital Center

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Washington Adventist Hospital

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North Mississippi Medical Center Cardiology Associates Research, LLC

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Boone Hospital Center

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Mercy Hospital Springfield

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Barnes Jewish Hospital

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St. Anthony's Medical Center

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St. Patrick Hospital

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Nebraska Heart Hospital

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Dartmouth-Hitchcock Medical Center

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Jersey Shore University Medical Center

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Presbyterian Hospital

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St. Joseph's Hospital Health Center

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Long Island Jewish Medical Center

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Winthrop University Hospital

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Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

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New York Presbyterian Hospital-Cornell University

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Lennox Hill Hospital,

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Rochester General Hospital

Rochester, New York, United States

Strong Memorial Hospital

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Stony Brook University Medical Center

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Montefiore Medical Center

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WakeMed

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Aultman Hospital

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University Hospital

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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EMH Healthcare

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Fairview Park, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

The Toledo Hospital

Toledo, Ohio, United States

Mercy St. Vincent's Medical Center

Toledo, Ohio, United States

Genesis-Good Samaritan Hospital

Zanesville, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Hillcrest Medical Center

Tulsa, Oklahoma, United States

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Portland, Oregon, United States

PeaceHealth Sacred Heart Medical Center

Springfield, Oregon, United States

Abington Memorial Hospital

Abington, Pennsylvania, United States

Holy Spirit Hospital

Camp Hill, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Erie, Pennsylvania, United States

St. Mary Medical Center

Langhorne, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Pinnacle Health at Harrisburg Hospital

Wormleysburg, Pennsylvania, United States

St. Joseph Medical Center

Wyomissing, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

The Miriam Hospital

Providence, Rhode Island, United States

AnMed Health

Anderson, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sisters of Charity Providence Hospital

Columbia, South Carolina, United States

Greenville Memorial Hospital of the Greenville Health System

Greenville, South Carolina, United States

St. Francis Health System

Greenville, South Carolina, United States

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Memorial Hospital

Chattanooga, Tennessee, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Turkey Creek Medical Center

Knoxville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Northwest Texas Healthcare System

Amarillo, Texas, United States

Seton Medical Center Austin

Austin, Texas, United States

Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Dallas, Texas, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Methodist Texsan Hospital

San Antonio, Texas, United States

East Texas Medical Center

Tyler, Texas, United States

Trinity Mother Frances Hospital Regional Healthcare Center

Tyler, Texas, United States

InterMountain Medical Center

Murray, Utah, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Mary Washington Hospital

Fredericksburg, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Winchester Medical Center

Winchester, Virginia, United States

St. Joseph Hospital

Bellingham, Washington, United States

Providence Regional Medical Center Everett

Everett, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

St. Mary's Medical Center

Huntington, West Virginia, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Countries

United States; Australia

References

Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.

Reference Type: DERIVED

PMID: 33893022 (View on PubMed)

Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.

Reference Type: DERIVED

PMID: 31561250 (View on PubMed)

Kereiakes DJ, Ellis SG, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, Tan SH, Ediebah DE, Simonton C, Stone GW; ABSORB III Investigators. Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial. Circulation. 2019 Dec 3;140(23):1895-1903. doi: 10.1161/CIRCULATIONAHA.119.042584. Epub 2019 Sep 25.

Reference Type: DERIVED

PMID: 31553222 (View on PubMed)

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Other Identifiers

10-392

Identifier Type: -

Identifier Source: org_study_id