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| ID | Type | Description | Link |
|---|---|---|---|
| AIDA trial | Registry Identifier | AIDA trial |
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To evaluate the efficacy and performance in an all-comers contemporary population of the ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.
The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. A total of 1845 patients were enrolled. The study population includes both simple and complex lesions, as well as stable and acute coronary syndrome patients. The follow-up will continue for 5 years including clinical endpoint characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABSORB BVS™ | Active Comparator | Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System |
|
| XIENCE™ | Active Comparator | XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABSORB BVS™ | Device | Bioresorbable scaffold |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | The primary composite endpoint is the device-oriented composite of target vessel failure (TVF):
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Successful delivery and deployment of the first study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 20% by quantitative coronary angiography (QCA) and thrombolysis in myocardial infarction (TIMI) 3 flow grade of the treated vessel. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Wykrzykowska, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Study Director |
| Rob de Winter, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Jan Piek, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Jan Tijssen, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Jose Henriques, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMC | Amsterdam | North Holland | 1105 AZ | Netherlands | ||
| Onze Lieve Vrouwe Gasthuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24439973 | Background | Woudstra P, Grundeken MJ, Kraak RP, Hassell ME, Arkenbout EK, Baan J Jr, Vis MM, Koch KT, Tijssen JG, Piek JJ, de Winter RJ, Henriques JP, Wykrzykowska JJ. Amsterdam Investigator-initiateD Absorb strategy all-comers trial (AIDA trial): a clinical evaluation comparing the efficacy and performance of ABSORB everolimus-eluting bioresorbable vascular scaffold strategy vs the XIENCE family (XIENCE PRIME or XIENCE Xpedition) everolimus-eluting coronary stent strategy in the treatment of coronary lesions in consecutive all-comers: rationale and study design. Am Heart J. 2014 Feb;167(2):133-40. doi: 10.1016/j.ahj.2013.09.017. Epub 2013 Oct 17. | |
| 34483094 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| XIENCE™ | Device | Drug eluting metallic stent |
|
|
| Procedural success | Achievement of final in-scaffold/stent residual stenosis of less than 20% by QCA and TIMI 3 flow grade of the treated vessel with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat Target Lesion Revascularization during the hospital stay. | 1 day |
| Target vessel failure (TVF) | Cardiac death, MI (not clearly attributable to a nontarget vessel) or target vessel revascularization | 30 days, and 1, 3, 4 and 5 years |
| Target lesion failure | Cardiac death, MI (not clearly attributable to a nontarget vessel) or target lesion revascularization | 30 days, and 1, 2, 3, 4 and 5 years |
| All revascularizations | 5 year |
| Major adverse cardiac events | All-cause mortality, any MI, any repeat revascularization | 30 days, and 1, 2, 3, 4 and 5 years |
| All cause mortality | 30 days, 1 year, 2, 3, 4 and 5 years |
| Myocardial Infarction | Q-wave Myocardial Infarction (QMI) and non Q-wave Myocardial Infarction (nonQMI)/target-vessel myocardial infarction (TVMI) and non-TVMI | 30 days, 1, 2, 3, 4 and 5 years |
| Target Lesion Revascularization (TLR) | 30 days, 1 year, 2, 3, 4 and 5 years |
| Target Vessel Revascularization (TVR) | 30 days, 1 year, 2, 3, 4 and 5 years |
| Non-Target Vessel Revascularization (NTVR) | 30 days, 1 year, 2, 3, 4 and 5 years |
| Scaffold/Stent Thrombosis | acute, subacute, late/definite and probable | 30 days, 1, 2, 3, 4 and 5 years |
| Seattle Angina Questionnaire (SAQ) | 1 year and 2 years |
| Quality of Life Questionnaire (QOL) | 1 year and 2 years |
| Amsterdam |
| Netherlands |
| Albert Schweitzer Hospital | Dordrecht | Netherlands |
| TerGooi Hospital | Hilversum | Netherlands |
| Medical Center Leeuwarden | Leeuwarden | Netherlands |
| Derived |
| Kerkmeijer LSM, Renkens MPL, Tijssen RYG, Hofma SH, van der Schaaf RJ, Arkenbout EK, Weevers APJD, Garcia-Garcia HM, Kraak R, Piek JJ, Tijssen JGP, Henriques JPS, de Winter RJ, Wykrzykowska JJ. Long-term clinical outcomes of everolimus-eluting bioresorbable scaffolds versus everolimus-eluting stents: final five-year results of the AIDA randomised clinical trial. EuroIntervention. 2022 Mar 18;17(16):1340-1347. doi: 10.4244/EIJ-D-21-00419. |
| 28402237 | Derived | Wykrzykowska JJ, Kraak RP, Hofma SH, van der Schaaf RJ, Arkenbout EK, IJsselmuiden AJ, Elias J, van Dongen IM, Tijssen RYG, Koch KT, Baan J Jr, Vis MM, de Winter RJ, Piek JJ, Tijssen JGP, Henriques JPS; AIDA Investigators. Bioresorbable Scaffolds versus Metallic Stents in Routine PCI. N Engl J Med. 2017 Jun 15;376(24):2319-2328. doi: 10.1056/NEJMoa1614954. Epub 2017 Mar 29. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |