ABSORB Post-Approval Clinical Study

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02943616
Study type	Interventional
Source	Abbott Vascular
Contact
Status	Withdrawn
Phase	N/A
Start date	August 2017
Completion date	January 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Active, not recruiting	`NCT04562805` - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)	N/A
Recruiting	`NCT05292079` - CAPTURER PMCF Study ( rEPIC04D )
Recruiting	`NCT05292118` - Navitian PMCF Study ( rEPIC04C )
Recruiting	`NCT05292092` - Essential Pro PMCF Study ( rEPIC04E )
Recruiting	`NCT05292014` - ANGIOLITE PMCF Study ( rEPIC04F )
Completed	`NCT05292105` - NC Xperience PMCF Study( rEPIC04B)
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Not yet recruiting	`NCT04153383` - Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
Recruiting	`NCT02982434` - The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation	Phase 2
Recruiting	`NCT02729064` - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose	Phase 1
Completed	`NCT02468401` - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions	N/A
Completed	`NCT02759406` - Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study	N/A
Recruiting	`NCT01681381` - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization	N/A
Completed	`NCT01604213` - Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease	Phase 4
Completed	`NCT01699802` - Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)	N/A
Completed	`NCT01724567` - Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training	N/A
Completed	`NCT01334268` - RESOLUTE China RCT	N/A
Completed	`NCT02159235` - Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.