ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.

Abbott

Status: Completed

Conditions: Coronary Artery Disease; Coronary Restenosis; Coronary Artery Stenosis; Chronic Total Occlusion of Coronary Artery; Coronary Disease; Coronary Artery Restenosis; Coronary Occlusion

Treatments: Device: Absorb Bioresorbable Vascular Scaffold

Study type: Observational

Funder types: Industry

Identifiers

NCT01759290

12-302

Details and patient eligibility

About

ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:

• Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
• To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s)
• Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.

Full description

the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.).

The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.

Enrollment: 1,800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:

  • Patient must be at least 18 years of age at the time of signing the Informed Consent Form
  • Patient is to be treated for de novo lesions located in previously untreated vessels.
  • Patient must agree to undergo all required follow-up visits and data collection.

Exclusion criteria

• The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:

  • Inability to obtain a signed informed consent from potential patient.
  • Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).

Trial design

1,800 participants in 1 patient group

Absorb Bioresorbable Vascular Scaffold

Description:

Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Treatment:

Device: Absorb Bioresorbable Vascular Scaffold