NCT02943616

ABSORB Post-Approval Clinical Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-12-01
• Completion: 2021-01-01
• First posted: 2016-10-25
• Last updated: 2018-01-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study