To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
NCT01977534 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1005
Last updated 2018-12-17
Summary
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
Conditions
- Coronary Disease
- Coronary Artery Disease
- Coronary Restenosis
Interventions
- DEVICE
-
Absorb BVS
The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating \[formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating\].
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Andreas Baumbach · Bristol Heart Institute
-
Susan Veldhof · Clinical Science
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2018-10-31
- Completion
- 2018-10-31
Countries
- United Kingdom
Study Locations
More Related Trials
-
Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina
NCT02707783 ·Status: COMPLETED
-
ABSORB Post-Approval Clinical Study
NCT02943616 ·Status: WITHDRAWN ·Phase: NA
-
The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study
NCT02973529 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease
NCT02932553 ·Status: WITHDRAWN ·Phase: PHASE4
-
The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT
NCT07162792 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Safety and Efficacy of Everolimus - Eluting Bioresorbable Vascular Scaffold for Cardiac Allograft Vasculopathy
NCT02377648 ·Status: COMPLETED ·Phase: PHASE4
-
Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)
NCT03069066 ·Status: UNKNOWN ·Phase: PHASE4
-
COmplex Bifurcation PCI: AXXESS Device + Absorb BVS, vs Modified T Stenting With Absorb BVS
NCT02628288 ·Status: UNKNOWN ·Phase: NA
-
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
NCT00232804 ·Status: COMPLETED ·Phase: PHASE4
-
Safety Study of a Bioresorbable Coronary Stent
NCT01262703 ·Status: COMPLETED ·Phase: NA
-
BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
NCT02817802 ·Status: ACTIVE_NOT_RECRUITING
-
Safety and Vascular Remodelling After BVS Implantation for Stenotic or Occluded Lesions in Children and Young Adults With KD.
NCT02771288 ·Status: UNKNOWN ·Phase: NA
-
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
NCT00231283 ·Status: COMPLETED ·Phase: PHASE3
-
Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds
NCT03518645 ·Status: COMPLETED ·Phase: NA
-
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions
NCT07258290 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Bioresorbable Vascular Scaffolds Versus Stents in Patients With Chronic Total Occlusion
NCT02739685 ·Status: TERMINATED ·Phase: NA
-
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
NCT02818972 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation
NCT02486315 ·Status: COMPLETED
-
Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries
NCT01258972 ·Status: COMPLETED ·Phase: NA
-
Evaluating the Use of the CapBuster System for the Crossing of CTO's in Coronary Arteries
NCT05733481 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of a XIENCE V® Endoprothesis Used for Coronary Angioplasty, for LPPR (List of Reimbursable Products and Services) Indications in Patients Monitored for 2 Years in France
NCT00987506 ·Status: COMPLETED
-
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)
NCT02650128 ·Status: COMPLETED ·Phase: NA
-
Bare Metal Bifurcation Stent Clinical Trial in Humans
NCT00607321 ·Status: COMPLETED ·Phase: NA
-
Shockwave Coronary Lithoplasty Study
NCT02758379 ·Status: COMPLETED ·Phase: NA
-
The Study to Evaluate Patient Outcome Using Distal Protection Combined With the BX Velocity.
NCT00264043 ·Status: COMPLETED ·Phase: PHASE2/PHASE3