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

Coronary Artery Disease Clinical Trial

Official title:

ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759290
• Other study ID #: 12-302
• Status: Completed
• Phase: N/A
• First received: December 14, 2012
• Last updated: February 9, 2016
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery
• Coronary Artery Disease
• Coronary Artery Restenosis
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Occlusion
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Device:
• Absorb Bioresorbable Vascular Scaffold
Subjects receiving the Absorb Bioresorbable Vascular Scaffold

Locations

Country	Name	City	State
Belgium	Abbott Vascular International BVBA	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death (Cardiovascular, Non-Cardiovascular)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	Death (Cardiovascular, Non-Cardiovascular)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	MI: QMI and NQMI, TV, and NTV	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	Target Lesion Revascularization (TLR): all TLR	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	TLR: all TLR	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	TLR: ischemic-driven (ID-TLR)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	TLR: ischemic-driven (ID-TLR)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	Target Vessel Revascularization (TVR): all TVR	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post procedure	Yes
Other	TVR: all TVR	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	TVR: ischemic-driven (ID-TVR)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	TVR: ischemic-driven (ID-TVR)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	All coronary revascularizations (Percutaneous Coronary Intervention (PCI) vs. Coronary Artery Bypass Graft (CABG))	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	All coronary revascularizations (PCI vs. CABG)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	Cardiac Death/All MI/ID-TLR (major adverse cardiac event (MACE))	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	Cardiac Death/All MI/ID-TLR (MACE)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	post-procedure	Yes
Other	Cardiac Death/All MI/ID-TVR (TVF)	Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	1 year	Yes
Other	Scaffold/Stent Thrombosis Timing (acute)	Definite, Probable. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	within 24 hours of index procedure	Yes
Other	Scaffold/Stent Thrombosis Timing (sub-acute)	Definite, Probable. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	>24 hours to 30 days	Yes
Other	Scaffold/Stent Thrombosis Timing (late)	Definite, Probable. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	>30 days to 1 year	Yes
Other	Acute Success: Clinical Device Success (lesion level analysis)	Achievement of a final in-scaffold residual diameter stenosis of < 50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	From start of index procedure to end of index procedure.	No
Other	Acute Success: Clinical Procedure Success (patient based analysis)	Achievement of a final in-scaffold diameter stenosis of < 50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure. Evaluated for the total registered patients, the subset of patients with 12 mm or shorter Absorb BVS, as well as the subset of patients with 18 mm Absorb BVS.	During the hospital stay with a maximum of 3 days post index procedure.	No
Primary	Cardiac Death/Target Vessel (TV)-Myocardial Infarction (MI)/Ischemic Driven (ID)-Target Lesion Revascularization (TLR) (Target Lesion Failure (TLF))	Cardiac Death/TV-MI/ID-TLR at 1 year for the 12 mm or shorter subgroup compared to the 18 mm subgroup.; The formal hypothesis is that the safety and performance of the 12 mm or shorter Absorb BVS is similar to the 18 mm Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment).; To evaluate this formal hypothesis, the observed Target Lesion Failure (TLF) rates at 1-year will be analyzed by a comparison between the 12 mm or shorter Absorb BVS and 18 mm Absorb BVS subgroups with confidence intervals. The analysis populations will have at least one corresponding size of Absorb BVS implanted but no more than two devices and up to two treated lesions.	1 year	Yes