Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial

NCT01858077 | Unknown DMC

• 2 other identifiers: COR 10341AIDA trial
• Study Type: interventional
• Target: 1,845
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Coronary Artery Disease; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Device success

  1 day

• Procedural success

  1 day

• Target vessel failure (TVF)

  30 days, and 1, 3, 4 and 5 years

• Target lesion failure

  30 days, and 1, 2, 3, 4 and 5 years

• All revascularizations

  5 year

Study Arms (2)

ABSORB BVS™

ACTIVE COMPARATOR

Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System

Device: ABSORB BVS™

XIENCE™

ACTIVE COMPARATOR

XIENCE PRIME everolimus eluting coronary stent system and the XIENCE Xpedition everolimus eluting coronary stent system

Device: XIENCE™

Interventions

ABSORB BVS™ DEVICE

Bioresorbable scaffold

Also known as: ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold, ABSORB, ABSORB BVS, BVS

ABSORB BVS™

XIENCE™ DEVICE

Drug eluting metallic stent

Also known as: XIENCE PRIME, XIENCE Xpedition, XIENCE, DES, Drug eluting stent

XIENCE™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (5)

AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

TerGooi Hospital

Hilversum, Netherlands

Location

Medical Center Leeuwarden

Leeuwarden, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 24439973 BACKGROUND

• 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.

  PMID: 34483094 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.

  PMID: 28402237 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J.J. Wykrzykowska, MD, PhD, Coordinating Investigator

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 21, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

NL (5)