Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
101 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-03-31
Study Completion Date
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.
Currently in development at Abbott Vascular. Not available for sale in the United States.
Currently in development at Abbott Vascular. Not available for sale in the United States.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
NCT00300131
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
COMPLETED
Absorb IV Randomized Controlled Trial
NCT02173379
Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
+1 more
COMPLETED
NA
ABSORB II Randomized Controlled Trial
NCT01425281
Coronary Artery Disease
COMPLETED
NA
ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease
NCT01583608
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
+7 more
COMPLETED
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
NCT01923740
Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
+1 more
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Absorb stent
Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)
Group Type
EXPERIMENTAL
Bioabsorbable Everolimus Eluting Coronary Stent
Intervention Type
DEVICE
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation in the treatment of coronary artery disease
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Patient must be at least 18 years of age.
2. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
5. Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
6. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure
1. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
2. Target lesion(s) must measure ≤ 14 mm in length by visual estimation
3. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1
2. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the BVS Everolimus Eluting CSS and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
5. Patient must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, intravascular ultrasound (IVUS), Palpography (optional), optical coherence tomography (OCT) (strongly recommended), multislice computed tomography (MSCT) (optional) and coronary vasomotion (optional)
6. Patient must agree not to participate in any other clinical investigation for a period of two years following the index procedure
1. Target lesion(s) must be located in a native coronary artery with visually estimated nominal vessel diameter of 3.0 mm
2. Target lesion(s) must measure ≤ 14 mm in length by visual estimation
3. Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 1
Exclusion Criteria
6. Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥ 90 days prior to or if planned to be done 6 months after the index procedure
7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure
1. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
2. The patient is currently experiencing clinical symptoms consistent with AMI
3. Patient has current unstable arrhythmias
4. Patient has a known left ventricular ejection fraction (LVEF) \< 30%
5. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
7. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
9. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated
10. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
11. Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a white blood cell count of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
15. Patient has had a significant GI or urinary bleed within the past six months
16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
17. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
18. Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
19. Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)
20. Patient has received brachytherapy in any epicardial vessel (including side branches)
1. Target lesion(s) meets any of the following criteria:
1. Aorto-ostial location (within 3 mm)
2. Left main location
3. Located within 2 mm of the origin of the LAD or LCX
4. Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \> 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
5. Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation
6. Total occlusion (TIMI flow 0), prior to wire crossing
7. Excessive tortuosity proximal to or within the lesion
8. Extreme angulation (≥ 90%) proximal to or within the lesion
9. Heavy calcification
10. Restenotic from previous intervention
2. The target vessel contains visible thrombus
3. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
4. Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
7. Non-Clinical Investigation percutaneous intervention for lesion in the target vessel is allowed if done \> 6 months prior to or if planned to be done 6 months after the index procedure
1. Patients has had a known diagnosis of acute myocardial infarction (AMI) within 3 days preceding the index procedure and creatine kinase (CK) and CK-MB have not returned within normal limits at the time of procedure
2. The patient is currently experiencing clinical symptoms consistent with AMI
3. Patient has current unstable arrhythmias
4. Patient has a known left ventricular ejection fraction (LVEF) \< 30%
5. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
6. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
7. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
8. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
9. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, everolimus, poly (L-lactide), poly (DL-lactide) or contrast sensitivity that cannot be adequately pre-medicated
10. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
11. Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a white blood cell count of \< 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
12. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis)
13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
15. Patient has had a significant GI or urinary bleed within the past six months
16. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
17. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
18. Patient is already participating in another clinical investigation that has not yet reached its primary endpoint
19. Pregnant or nursing patients and those who plan pregnancy during the Clinical Investigation. (Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure and effective contraception must be used during participation in this Clinical Investigation)
20. Patient has received brachytherapy in any epicardial vessel (including side branches)
1. Target lesion(s) meets any of the following criteria:
1. Aorto-ostial location (within 3 mm)
2. Left main location
3. Located within 2 mm of the origin of the LAD or LCX
4. Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and \> 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft
5. Lesion involving a bifurcation ≥ 2 mm in diameter and ostial lesion \> 40% stenosed by visual estimation or side branch requiring predilatation
6. Total occlusion (TIMI flow 0), prior to wire crossing
7. Excessive tortuosity proximal to or within the lesion
8. Extreme angulation (≥ 90%) proximal to or within the lesion
9. Heavy calcification
10. Restenotic from previous intervention
2. The target vessel contains visible thrombus
3. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion(s) (including side branches)
4. Patient has a high probability that a procedure other than pre-dilatation and stenting and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon or brachytherapy)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Medical Devices
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick Serruys, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Heart Center, Thorax Centrum
John Ormiston, MD
Role: PRINCIPAL_INVESTIGATOR
Auckland City Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Vincent's Hospital
Melbourne, Victoria, Australia
Site Status
Monash Heart
Melbourne, , Australia
Site Status
Onze-Lieve VrouweZiekenhuis
Aalst, , Belgium
Site Status
Skejby Sygehus
Aarhus, , Denmark
Site Status
Institut Hospitalier Jacques Cartier
Massy, , France
Site Status
Catharina ZH Eindhoven
Eindhoven, , Netherlands
Site Status
Erasmus Medical Center
Rotterdam, , Netherlands
Site Status
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Site Status
Auckland City Hospital
Auckland, , New Zealand
Site Status
Christchurch Hospital
Christchurch, , New Zealand
Site Status
Jagiellonian University
Krakow, , Poland
Site Status
Inselspital Bern, Kardiologie
Bern, , Switzerland
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Australia
Belgium
Denmark
France
Netherlands
New Zealand
Poland
Switzerland
References
Explore related publications, articles, or registry entries linked to this study.
Zeng Y, Cavalcante R, Collet C, Tenekecioglu E, Sotomi Y, Miyazaki Y, Katagiri Y, Asano T, Abdelghani M, Nie S, Bourantas CV, Bruining N, Onuma Y, Serruys PW. Coronary calcification as a mechanism of plaque/media shrinkage in vessels treated with bioresorbable vascular scaffold: A multimodality intracoronary imaging study. Atherosclerosis. 2018 Feb;269:6-13. doi: 10.1016/j.atherosclerosis.2017.11.002. Epub 2017 Dec 2.
Reference Type
DERIVED
Onuma Y, Grundeken MJ, Nakatani S, Asano T, Sotomi Y, Foin N, Ng J, Okamura T, Wykrzykowska JJ, de Winter RJ, van Geuns RJ, Koolen J, Christiansen EH, Whitbourn R, McClean D, Smits P, Windecker S, Ormiston JA, Serruys PW. Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). Circ Cardiovasc Interv. 2017 Sep;10(9):e004393. doi: 10.1161/CIRCINTERVENTIONS.116.004393.
Reference Type
DERIVED
Zeng Y, Tateishi H, Cavalcante R, Tenekecioglu E, Suwannasom P, Sotomi Y, Collet C, Nie S, Jonker H, Dijkstra J, Radu MD, Raber L, McClean DR, van Geuns RJ, Christiansen EH, Fahrni T, Koolen J, Onuma Y, Bruining N, Serruys PW. Serial Assessment of Tissue Precursors and Progression of Coronary Calcification Analyzed by Fusion of IVUS and OCT: 5-Year Follow-Up of Scaffolded and Nonscaffolded Arteries. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1151-1161. doi: 10.1016/j.jcmg.2016.11.016. Epub 2017 Mar 15.
Reference Type
DERIVED
Onuma Y, Collet C, van Geuns RJ, de Bruyne B, Christiansen E, Koolen J, Smits P, Chevalier B, McClean D, Dudek D, Windecker S, Meredith I, Nieman K, Veldhof S, Ormiston J, Serruys PW; ABSORB Investigators. Long-term serial non-invasive multislice computed tomography angiography with functional evaluation after coronary implantation of a bioresorbable everolimus-eluting scaffold: the ABSORB cohort B MSCT substudy. Eur Heart J Cardiovasc Imaging. 2017 May 1;18(8):870-879. doi: 10.1093/ehjci/jex022.
Reference Type
DERIVED
Serruys PW, Ormiston J, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Chevalier B, Smits P, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Wasungu L, Ediebah D, Veldhof S, Onuma Y. A Polylactide Bioresorbable Scaffold Eluting Everolimus for Treatment of Coronary Stenosis: 5-Year Follow-Up. J Am Coll Cardiol. 2016 Feb 23;67(7):766-76. doi: 10.1016/j.jacc.2015.11.060.
Reference Type
DERIVED
Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.
Reference Type
DERIVED
Karanasos A, Garcia-Garcia HM, van Geuns RJ, Regar E. Fate of side-branch jailing and a malapposed platinum marker after resorption of an everolimus-eluting bioresorbable vascular scaffold: serial optical coherence tomography observations. JACC Cardiovasc Interv. 2015 Mar;8(3):e53-e54. doi: 10.1016/j.jcin.2014.10.020. No abstract available.
Reference Type
DERIVED
Onuma Y, Serruys PW, Muramatsu T, Nakatani S, van Geuns RJ, de Bruyne B, Dudek D, Christiansen E, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Garcia-Garcia HM, Veldhof S, Rapoza R, Ormiston JA. Incidence and imaging outcomes of acute scaffold disruption and late structural discontinuity after implantation of the absorb Everolimus-Eluting fully bioresorbable vascular scaffold: optical coherence tomography assessment in the ABSORB cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2014 Dec;7(12):1400-11. doi: 10.1016/j.jcin.2014.06.016.
Reference Type
DERIVED
Zhang YJ, Iqbal J, Nakatani S, Bourantas CV, Campos CM, Ishibashi Y, Cho YK, Veldhof S, Wang J, Onuma Y, Garcia-Garcia HM, Dudek D, van Geuns RJ, Serruys PW; ABSORB Cohort B Study Investigators. Scaffold and edge vascular response following implantation of everolimus-eluting bioresorbable vascular scaffold: a 3-year serial optical coherence tomography study. JACC Cardiovasc Interv. 2014 Dec;7(12):1361-9. doi: 10.1016/j.jcin.2014.06.025. Epub 2014 Nov 12.
Reference Type
DERIVED
Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
Reference Type
DERIVED
Serruys PW, Onuma Y, Garcia-Garcia HM, Muramatsu T, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Ormiston JA. Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months. EuroIntervention. 2014 Mar 20;9(11):1271-84. doi: 10.4244/EIJV9I11A217.
Reference Type
DERIVED
Ormiston JA, Serruys PW, Onuma Y, van Geuns RJ, de Bruyne B, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Rapoza R, Garcia-Garcia HM. First serial assessment at 6 months and 2 years of the second generation of absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study. Circ Cardiovasc Interv. 2012 Oct;5(5):620-32. doi: 10.1161/CIRCINTERVENTIONS.112.971549. Epub 2012 Oct 9.
Reference Type
DERIVED
Gutierrez-Chico JL, Gijsen F, Regar E, Wentzel J, de Bruyne B, Thuesen L, Ormiston J, McClean DR, Windecker S, Chevalier B, Dudek D, Whitbourn R, Brugaletta S, Onuma Y, Serruys PW. Differences in neointimal thickness between the adluminal and the abluminal sides of malapposed and side-branch struts in a polylactide bioresorbable scaffold: evidence in vivo about the abluminal healing process. JACC Cardiovasc Interv. 2012 Apr;5(4):428-35. doi: 10.1016/j.jcin.2011.12.015.
Reference Type
DERIVED
Brugaletta S, Radu MD, Garcia-Garcia HM, Heo JH, Farooq V, Girasis C, van Geuns RJ, Thuesen L, McClean D, Chevalier B, Windecker S, Koolen J, Rapoza R, Miquel-Hebert K, Ormiston J, Serruys PW. Circumferential evaluation of the neointima by optical coherence tomography after ABSORB bioresorbable vascular scaffold implantation: can the scaffold cap the plaque? Atherosclerosis. 2012 Mar;221(1):106-12. doi: 10.1016/j.atherosclerosis.2011.12.008. Epub 2011 Dec 13.
Reference Type
DERIVED
Gutierrez-Chico JL, Radu MD, Diletti R, Sheehy A, Kossuth MB, Oberhauser JP, Glauser T, Harrington J, Rapoza RJ, Onuma Y, Serruys PW. Spatial distribution and temporal evolution of scattering centers by optical coherence tomography in the poly(L-lactide) backbone of a bioresorbable vascular scaffold. Circ J. 2012;76(2):342-50. doi: 10.1253/circj.cj-11-0726. Epub 2011 Nov 19.
Reference Type
DERIVED
Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.
Reference Type
DERIVED
Gomez-Lara J, Radu M, Brugaletta S, Farooq V, Diletti R, Onuma Y, Windecker S, Thuesen L, McClean D, Koolen J, Whitbourn R, Dudek D, Smits PC, Regar E, Veldhof S, Rapoza R, Ormiston JA, Garcia-Garcia HM, Serruys PW. Serial analysis of the malapposed and uncovered struts of the new generation of everolimus-eluting bioresorbable scaffold with optical coherence tomography. JACC Cardiovasc Interv. 2011 Sep;4(9):992-1001. doi: 10.1016/j.jcin.2011.03.020.
Reference Type
DERIVED
Gomez-Lara J, Brugaletta S, Farooq V, van Geuns RJ, De Bruyne B, Windecker S, McClean D, Thuesen L, Dudek D, Koolen J, Whitbourn R, Smits PC, Chevalier B, Morel MA, Dorange C, Veldhof S, Rapoza R, Garcia-Garcia HM, Ormiston JA, Serruys PW. Angiographic geometric changes of the lumen arterial wall after bioresorbable vascular scaffolds and metallic platform stents at 1-year follow-up. JACC Cardiovasc Interv. 2011 Jul;4(7):789-99. doi: 10.1016/j.jcin.2011.04.009.
Reference Type
DERIVED
Gutierrez-Chico JL, Serruys PW, Girasis C, Garg S, Onuma Y, Brugaletta S, Garcia-Garcia H, van Es GA, Regar E. Quantitative multi-modality imaging analysis of a fully bioresorbable stent: a head-to-head comparison between QCA, IVUS and OCT. Int J Cardiovasc Imaging. 2012 Mar;28(3):467-78. doi: 10.1007/s10554-011-9829-y. Epub 2011 Feb 26.
Reference Type
DERIVED
Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.
Reference Type
DERIVED
Gomez-Lara J, Garcia-Garcia HM, Onuma Y, Garg S, Regar E, De Bruyne B, Windecker S, McClean D, Thuesen L, Dudek D, Koolen J, Whitbourn R, Smits PC, Chevalier B, Dorange C, Veldhof S, Morel MA, de Vries T, Ormiston JA, Serruys PW. A comparison of the conformability of everolimus-eluting bioresorbable vascular scaffolds to metal platform coronary stents. JACC Cardiovasc Interv. 2010 Nov;3(11):1190-8. doi: 10.1016/j.jcin.2010.07.016.
Reference Type
DERIVED
Okamura T, Onuma Y, Garcia-Garcia HM, Regar E, Wykrzykowska JJ, Koolen J, Thuesen L, Windecker S, Whitbourn R, McClean DR, Ormiston JA, Serruys PW; ABSORB Cohort B Investigators. 3-Dimensional optical coherence tomography assessment of jailed side branches by bioresorbable vascular scaffolds: a proposal for classification. JACC Cardiovasc Interv. 2010 Aug;3(8):836-44. doi: 10.1016/j.jcin.2010.05.011.
Reference Type
DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05-370 Cohort B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
ABSORB III Randomized Controlled Trial (RCT)
NCT01751906
COMPLETED
NA
ABSORB PHYSIOLOGY Clinical Investigation
NCT01308346
TERMINATED
NA
ABSORB STEMI: the TROFI II Study
NCT01986803
COMPLETED
NA
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
NCT02486068
UNKNOWN
NA
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
NCT02229864
COMPLETED
NA
Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction
NCT02890589
COMPLETED
NA
Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold
NCT02066623
COMPLETED
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
NCT02831205
TERMINATED
PHASE4
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
NCT01120379
COMPLETED
Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
NCT01995487
COMPLETED
NA
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
NCT01844284
COMPLETED
NA
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
NCT00676520
COMPLETED
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
NCT02474485
SUSPENDED
NA
First in Man Trial - BIOSOLVE-I
NCT01168830
COMPLETED
NA
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
NCT00180310
COMPLETED
PHASE3
Vessel Wall Response of the Bio-Active-stent and Everolimus-Eluting Stent Assessed By Optical Coherence Tomography
NCT01080859
COMPLETED
Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial
NCT01858077
UNKNOWN
NA
Study of ABSORB Stent in Acute Myocardial Infarction
NCT02071342
UNKNOWN
Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions
NCT07022587
RECRUITING
NA
Study of the Orsiro Drug Eluting Stent System
NCT01356888
UNKNOWN
NA
XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery
NCT00731237
COMPLETED
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
NCT01249027
COMPLETED
Everolimus-eluting SYNERGY Stent Versus Biolimus-eluting Biomatrix NeoFlex Stent - SORT-OUT VIII
NCT02093845
UNKNOWN
NA
The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
NCT01665053
COMPLETED
PHASE3
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
NCT01894152
COMPLETED