Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial

Coronary Artery Disease Clinical Trial

— AIDA  

Official title:

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 Versus the XIENCE Family (XIENCE PRIME™ or XIENCE Xpedition™) Everolimus Eluting Coronary Stent Strategy in the Treatment of Coronary Lesions in Consecutive All-comers.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01858077
• Other study ID #: COR 10341
• Secondary ID: AIDA trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2013
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1845
• Est. completion date: December 2020
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the ABSORB BVS strategy and XIENCE family.

• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy 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.

Exclusion Criteria:

• Subject is younger than 18 years of age

• Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.

• Unsuccessful predilation of one or more of the planned lesion to be treated.

• Planned treatment of in-stent restenosis of a previously placed metallic stent.

• Subject has one or more lesion planned to be treated with a scaffold/stent diameter size smaller than 2.5 mm or greater than 4.0 mm.

• Subject has one or more lesion planned to be treated with a stent/scaffold length greater than 70 mm and/or overlapping of four or more scaffolds/stents.

• Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.

• Subjects pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)

• Subjects with a limited life expectancy less than one year.

• Subjects with factors that impede clinical follow-up (e.g. no fixed abode).

• Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.

• Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• ABSORB BVS™
Bioresorbable scaffold
• XIENCE™
Drug eluting metallic stent

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam	Noord-Holland
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Albert Schweitzer Hospital	Dordrecht
Netherlands	TerGooi Hospital	Hilversum
Netherlands	Medical Center Leeuwarden	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure (TVF)	The primary composite endpoint is the device-oriented composite of target vessel failure (TVF): Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	All revascularizations		5 year
Secondary	Major adverse cardiac events	All-cause mortality, any MI, any repeat revascularization	30 days, and 1, 2, 3, 4 and 5 years
Secondary	All cause mortality		30 days, 1 year, 2, 3, 4 and 5 years
Secondary	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
Secondary	Target Lesion Revascularization (TLR)		30 days, 1 year, 2, 3, 4 and 5 years
Secondary	Target Vessel Revascularization (TVR)		30 days, 1 year, 2, 3, 4 and 5 years
Secondary	Non-Target Vessel Revascularization (NTVR)		30 days, 1 year, 2, 3, 4 and 5 years
Secondary	Scaffold/Stent Thrombosis	acute, subacute, late/definite and probable	30 days, 1, 2, 3, 4 and 5 years
Secondary	Seattle Angina Questionnaire (SAQ)		1 year and 2 years
Secondary	Quality of Life Questionnaire (QOL)		1 year and 2 years