ABSORB Post-Approval Clinical Study

NCT02943616 | Withdrawn DMC FDA Device

• 1 other identifier: 15-307
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world setting following commercial physician training'and to observe the effectiveness of commercial physician training on appropriate vessel sizing.

Conditions

Ischemic Heart Disease

Keywords

Absorb GT1 BVS; BVS; Bioabsorbable; Myocardial ischemia; Stent thrombosis; Stents

Outcome Measures

Primary Outcomes (1)

• Composite of cardiac death, myocardial infarction (CD/MI)

  Myocardial infarction will be assessed per the Universal MI definition.

  1 year

Secondary Outcomes (75)

• Definite/probable scaffold thrombosis (ST)

  1 year

• The annual rate of definite/probable scaffold thrombosis

  At 1 year post-index procedure

• The annual rate of definite/probable scaffold thrombosis

  Between 1 year and 2 years (366 to 730 days) post index procedure

• The annual rate of definite/probable scaffold thrombosis

  Between 2 years and 3 years (731 to 1095 days) post index procedure

• Percentage of very small vessels (per-lesion basis)

  Pre-procedure (on day 0)

Study Arms (1)

Absorb BVS

EXPERIMENTAL

Subjects receiving Absorb GT1 Bioresorbable Vascular Scaffold (BVS).

Device: Absorb BVS

Interventions

Absorb BVS DEVICE

Commercially approved Absorb GT1 BVS, herein referred to as "Absorb". * Scaffold diameters: 2.5, 3.0, and 3.5 mm * Scaffold lengths: 8, 12, 18, 23 and 28 mm Absorb is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients 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.

Absorb BVS

Eligibility Criteria

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

You may qualify if:

• The subject agrees and signs the Institutional Review Board (IRB) approved informed consent form
• The subject receives an Absorb

You may not qualify if:

• Subject is a member of a vulnerable population.
• Vulnerable population: Defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: Individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (5)

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Franciscan St. Francis Health

Indianapolis, Indiana, 46237, United States

Location

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Peter Staehr

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 25, 2016
• Study Start: August 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2021
• Last Updated: January 11, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)