Abbott Next Generation Drug Eluting Stent 48mm Study

NCT04282148 | Completed Results DMC FDA Device

• 1 other identifier: ABT-CIP-10321
• Study Type: interventional
• Target: 107
• Locations: 3 countries
• Sites: 25

Brief Summary

The purpose of this SPIRIT 48 study is to evaluate the safety and effectiveness of the ABT NG DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease (CAD) due to de novo native coronary artery long lesions.

Conditions

Coronary Artery Disease

Keywords

De novo native coronary artery long lesions; ABT NG DES 48 EECSS; ABT-CIP-10321; Coronary artery luminal diameter; SPIRIT 48

Outcome Measures

Primary Outcomes (1)

• Kaplan-Meier Estimate of 1-Year Target Lesion Failure (TLF)

  Target Lesion Failure (TLF) is defined as the composite rate of cardiac death (CD), target vessel myocardial infarction \[TV-MI\] (per SCAI MI definition), and clinically indicated target lesion revascularization \[CI-TLR\])

  1 year

Secondary Outcomes (5)

• Number of Participants With Target Lesion Failure (TLF)

  In-hospital 6 to 12 hours post procedure

• Number of Participants With Target Lesion Failure (TLF)

  30 days

• Number of Participants With Target Lesion Failure (TLF)

  180 days

• Number of Participants With Target Lesion Failure (TLF)

  1 year

• Number of Participants With Target Lesion Failure (TLF)

  2 year

Study Arms (1)

ABT NG DES 48 EECSS

EXPERIMENTAL

Participants will receive ABT NG DES 48 EECSS device

Device: ABT NG DES 48 EECSS

Interventions

ABT NG DES 48 EECSS DEVICE

Each participant will receive ABT NG DES 48 EECSS with appropriate diameter

ABT NG DES 48 EECSS

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.
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements.
• Subject must have evidence of myocardial ischemia (e.g., unstable angina, post-infarct angina, stable angina or silent ischemia) suitable for non-emergent PCI. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following,
• Abnormal stress or imaging stress test
• Abnormal computed tomography-fractional flow reserve (CT-FFR)
• Stenosis by visual estimation ≥ 70%
• Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio \[iFR\], or relative flow reserve \[RFR\])
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
• Only one de novo target lesion in native coronary artery is allowed to be treated with the investigational stent.
• One additional non-target lesion can be treated if it is located in a different epicardial coronary vessel and NOT in left main coronary artery. The non-target lesion must be treated first and must be deemed an angiographic success.
• The target lesion must be located in a native coronary artery with:
• Visually estimated reference vessel diameter (RVD) of ≥ 2.5 mm and ≤ 4.25 mm.
• Visually estimated lesion length of \> 32 mm and ≤ 44 mm, and able to be covered by a single ABT NG DES 48.
• a. Multiple focal de novo lesions in an epicardial coronary vessel are allowed if the lesions can be covered by one stent. Multiple focal de novo lesions will be counted as a single lesion.

You may not qualify if:

• Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoropolymers, etc.), or has known contrast sensitivity.
• Subject has known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, P2Y12 inhibitors (clopidogrel /prasugrel /ticagrelor), and therefore cannot be adequately pre-medicated.
• Subject has a planned surgery or procedure necessitating discontinuation of aspirin or P2Y12 inhibitor within 12 months following index procedure.
• Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
• Subject had an acute myocardial infarction (AMI) within 48 hours of the index procedure with either of the situations below:
• The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic electrocardiogram (ECG) changes
• Elevated cardiac biomarker values have not returned to within normal limits at the time of index procedure.
• Subject has a left ventricular ejection fraction (LVEF) \< 30% within 3 months prior to the index procedure, that was documented by any method.
• Subject is expected to require percutaneous mechanical cardiac support at the index procedure.
• Prior PCI within the target vessel during the last 12 months prior to consent.
• Prior PCI within the non-target vessel or any peripheral intervention during the last 30 days prior to consent.
• At the index procedure, subject is identified to require planned stenting procedure (including staged procedures) or CABG after the index procedure.
• Subject has received a solid organ transplant which is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
• Subject has a malignancy that is not in remission.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (25)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

Scripps Memorial Hospital - La Jolla

La Jolla, California, 92037, United States

Location

UCLA Medical Center Santa Monica

Santa Monica, California, 90404, United States

Location

The Cardiac & Vascular Institute Research Foundation, LLC

Gainesville, Florida, 32605, United States

Location

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

Mount Sinai Hospital

New York, New York, 10019, United States

Location

The Lindner Center

Cincinnati, Ohio, 45219, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Pinnacle Health System

Harrisburg, Pennsylvania, 17105, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Baylor Scott & White Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal North Shore Hospital

St Leonards, 2065, Australia

Location

Chang Gung Memorial Hospital

Linkou District, North Taiwan, 333, Taiwan

Location

National Taiwan University Hospital

Taipei, North Taiwan, 10002, Taiwan

Location

Cheng Hsin General Hospital

Taipei, North Taiwan, 112, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, South Taiwan, 83301, Taiwan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ikuko Kishimoto, Principal Research Scientist
• Organization: Abbott

ikuko.kishimoto@abbott.com

480-482-8279

Study Officials

• Chi-Jen Chang, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Ki E Park, MD

  University of Florida/Malcom Randall VAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, global (US and OUS)

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: June 17, 2020
• Primary Completion: October 5, 2022
• Study Completion: September 17, 2023
• Last Updated: January 8, 2025
• Results First Posted: February 12, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); AU (3); TW (4)