A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)

NCT01923740 | Completed Results DMC

• 1 other identifier: 12-397
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

Conditions

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

Keywords

Absorb™ BVS; Angioplasty; Bioabsorbable; BVS; Bioresorbable; Coronary Artery Disease; Coronary Artery Endothelial Responsiveness; Coronary artery restenosis; Coronary artery stenosis; Coronary scaffold; Coronary Stent; Drug eluting stents; Everolimus; Myocardial ischemia; Stent thrombosis; Stents

Outcome Measures

Primary Outcomes (2)

• In-segment Late Loss (LL) - Per Subject Analysis

  In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

  1 year

• In-segment Late Loss (LL) - Per Lesion Analysis

  In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.

  1 year

Secondary Outcomes (127)

• Acute Device Success

  < or = 1 day

• Number of Participants With Acute Procedural Success

  At time of procedure up to 7 days in hospital

• Number of Death (Cardiac, Vascular, Non-cardiovascular)

  ≤ 7 days post index procedure (In-hospital )

• Number of Death (Cardiac, Vascular, Non-cardiovascular)

  0 to 37days

• Number of Death (Cardiac, Vascular, Non-cardiovascular)

  0 to 208 days

Study Arms (2)

Absorb BVS System

EXPERIMENTAL

Absorb BVS System: Subjects receiving Absorb BVS System

Device: Absorb BVS System

XIENCE V EECSS

ACTIVE COMPARATOR

XIENCE V EECSS: Subjects receiving XIENCE V

Device: XIENCE V EECSS

Interventions

XIENCE V EECSS DEVICE

Subjects receiving XIENCE V

XIENCE V EECSS

Absorb BVS System DEVICE

Subjects receiving Absorb BVS System

Absorb BVS System

Eligibility Criteria

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

You may qualify if:

• Subject must be at least 18 years of age at the time of signing the informed consent form.
• Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
• Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and \< 70% diameter stenosis must have objective 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.
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Female subject of childbearing potential 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 14 days (≤14 days) prior to the index procedure per site standard test.
• 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.
• Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure.

You may not qualify if:

• Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure.
• Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
• Subject has a known allergic reaction, hypersensitivity or contraindication to:
• Aspirin; or
• All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or
• Heparin and bivalirudin.
• Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure.
• Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
• Subject has a cardiac arrhythmia as identified at the time of screening which at least one of the following criteria is met:
• Subject requires coumadin or any other agent for chronic oral anticoagulation.
• Subject likely to become hemodynamically unstable due to their arrhythmia.
• Subject has poor survival prognosis due to their arrhythmia.
• Subject has a known left ventricular ejection fraction (LVEF) \< 30% assessed by any quantitative method. LVEF may be obtained within 6 months prior to the procedure for subjects with stable coronary artery disease (CAD). For subjects presenting with acute coronary syndrome (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.
• Subject has received CABG at any time in the past.
• Subject has undergone prior PCI within the target vessel during the last 12 months or undergone prior PCI within the non-target vessel within 30 days before the index procedure.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Vascular

Santa Clara, California, 95054, United States

Location

Related Publications (4)

• 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.

  PMID: 31561250 DERIVED

• Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.

  PMID: 29089314 DERIVED

• Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.

  PMID: 26825231 DERIVED

• Gao R, Yang Y, Han Y, Huo Y, Chen J, Yu B, Su X, Li L, Kuo HC, Ying SW, Cheong WF, Zhang Y, Su X, Xu B, Popma JJ, Stone GW; ABSORB China Investigators. Bioresorbable Vascular Scaffolds Versus Metallic Stents in Patients With Coronary Artery Disease: ABSORB China Trial. J Am Coll Cardiol. 2015 Dec 1;66(21):2298-2309. doi: 10.1016/j.jacc.2015.09.054. Epub 2015 Oct 12.

  PMID: 26471805 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Siok Hwee Tan
• Organization: Abbott Vascular

siokhwee.tan@abbott.com

+1 408-845-3581

Study Officials

• Gao Runlin, MD, FACC

  Fu Wai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 16, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: March 7, 2019
• Last Updated: December 4, 2019
• Results First Posted: February 14, 2018

Record last verified: 2019-08

Locations

US (1)