NCT01106534 (XVU-AV DAPT) is a Phase 4 clinical trial of clopidogrel + aspirin OR prasugrel + aspirin in Chronic Total Occlusion of Coronary Artery, sponsored by Abbott Medical Devices.

Who is sponsoring NCT01106534?

NCT01106534 is sponsored by Abbott Medical Devices.

What drugs are being tested in NCT01106534?

Interventions in NCT01106534: placebo + aspirin, clopidogrel + aspirin OR prasugrel + aspirin, XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS).

What condition does NCT01106534 study?

NCT01106534 studies Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis.

Is NCT01106534 still recruiting?

NCT01106534 is currently completed. Last updated 27 October 2023.

Are results published for NCT01106534?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-10-27 · How we verify

NCT01106534: XVU-AV DAPT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

XIENCE V® Everolimus Eluting Coronary Stent System USA Post- Approval Study (XIENCE V® USA DAPT Cohort) (XVU-AV DAPT)

Completed Phase 4 Results posted Last updated 27 October 2023

What this trial tests

Phase 4 trial testing placebo + aspirin in Chronic Total Occlusion of Coronary Artery in 870 participants. Completed in 1 July 2015.

Timeline

1 August 2009

Primary endpoint
1 February 2015

1 July 2015

Quick facts

Lead sponsor	Abbott Medical Devices
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	870
Start date	1 August 2009
Primary completion	1 February 2015
Estimated completion	1 July 2015
Sites	144 locations across United States

Drugs / interventions tested

placebo + aspirin
clopidogrel + aspirin OR prasugrel + aspirin — full drug profile →
XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)

Conditions studied

Chronic Total Occlusion of Coronary Artery — all drugs for Chronic Total Occlusion of Coronary Artery →
Vascular Disease — all drugs for Vascular Disease →
Myocardial Ischemia — all drugs for Myocardial Ischemia →
Coronary Artery Stenosis — all drugs for Coronary Artery Stenosis →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Chronic Total Occlusion of Coronary Artery or Vascular Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence of Composite of All Death, MI and Stroke (Defined as MACE)
Time frame: 12-33 months post-stent
Incidence of ARC Definite or Probable ST
Time frame: 12-33 months post-stent
Major Bleeding (GUSTO Classification, Severe and Moderate Bleeding Combined)
Time frame: 12-33 months post-stent

Sponsor's own description

XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are * To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and * To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Editors' Picks for 2014 and a Look into the Future.
Giugliano RP, Zeymer U, Menown I. · · 2015 · PMID 25766962 · DOI 10.1007/s40119-015-0038-y

Verify or expand the search:

Other recruiting trials for Chronic Total Occlusion of Coronary Artery

Currently open trials in the same condition.

NCT06414551 — Calcification on CTCA of a CTO and PCI Outcomes · recruiting
NCT06193954 — VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions · NA · recruiting
NCT03756870 — Revascularization Versus Optimal Medical Therapy of Chronic Total Coronary Occlusions on Left Ventricular Ischemia Reduc · NA · recruiting
NCT03563417 — ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO · NA · recruiting
NCT03392415 — The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in Chronic Total Coronary Occlusion · NA · active not recruiting

Other Abbott Medical Devices trials

Trials by the same sponsor.

NCT07421076 — Grid eXplore Mapping Study · NA · recruiting
NCT07509658 — TriClip Japan Post-Approval Study · recruiting
NCT07361445 — Agilis RF TSP Early Feasibility Study · NA · recruiting
NCT07373353 — A Clinical Evaluation of AMJ-401 · NA · recruiting
NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01106534 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
Last refreshed: 27 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01106534.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing