ABSORB Post-Approval Clinical Study

NCT ID: NCT02943616

Last Updated: 2018-01-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-31
• Study Completion Date: 2021-01-31

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.

Detailed Description

After approval of commercial use of Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System in over 75 countries as of December 31, 2015, Abbott Vascular has developed a post-approval commitment plan that includes the initiation of the ABSORB Post-Approval Clinical Study, a single-arm trial that will include approximately 2000 subjects at approximately 265 sites in the US and Canada.

The objectives of ABSORB PostApproval Study are the following:

• Evaluate the safety of the use of Absorb in a real world setting following commercial physician training.
• Observe the effectiveness of commercial physician training on appropriate vessel sizing in the use of Absorb in a real world setting.

The study design allows evaluating low frequency events, effectiveness of commercial physician training and education for very small vessels (< 2.25 mm as assessed by quantitative coronary angiography [QCA]), and confirmation of generalizability of the treatment with Absorb to real-world practice. The estimated follow-up of safety and effectiveness will be 3 years.

Angiographic Subgroup:

Approximately the first 500 consecutive subjects implanted by operators inexperienced in the usage of Absorb GT1 BVS to receive baseline assessment of reference vessel diameter (RVD) by the angiographic core laboratory. An inexperienced operator is defined as having performed two or fewer Absorb implants prior to commercial approval. The purpose of the angiographic subgroup is to evaluate the effectiveness of training in the selection of appropriately sized coronary arteries for GT1 BVS implantation. Study staff will be notified after the procedure if the subject is in the angiographic subgroup, and instructed to send pre-procedure angiogram and supporting materials to core laboratory for assessment.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Absorb BVS

Subjects receiving Absorb GT1 Bioresorbable Vascular Scaffold (BVS).

Group Type: EXPERIMENTAL

Absorb BVS

Intervention Type: 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.

Interventions

Absorb BVS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• 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

Peter Staehr

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Franciscan St. Francis Health

Indianapolis, Indiana, United States

Baptist Health Louisville

Louisville, Kentucky, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Turkey Creek Medical Center

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

15-307

Identifier Type: -

Identifier Source: org_study_id