Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation (ACO_FLEX)

April 21, 2026 updated by: Fundación EPIC
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain, 02008
        • Recruiting
        • Hospital General Universitario de Albacete
      • Alicante, Spain, 03550
        • Recruiting
        • Hospital Universitario San Juan de Alicante
      • Badajoz, Spain, 6800
        • Recruiting
        • Hospital General Universitario de Merida
      • Castelló, Spain, 12004
        • Recruiting
        • Hospital General Universitari de Castelló
      • Ciudad Real, Spain, 13005
        • Recruiting
        • H.G.U. de Ciudad Real.
      • Elche, Spain, 03203
        • Recruiting
        • Hospital General Universitari d'Elx
      • Laguna, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
      • Pamplona, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients under chronic oral anticoagulation undergoing PCI with implantation of a SupraFlex Cruz(r) stent

Description

Inclusion Criteria:

Patients must meet all inclusion criteria:

  • Patients with Signed informed consent and
  • Patients with >=18 years old and
  • Patients with chronically receiving oral anticoagulation treatment with any type of anticoagulant for any reason and
  • Patients with de novo Coronary artery disease requiring both elective or urgent percutaneous revascularization due to stable coronary artery disease or acute coronary syndrome with or without ST-segment elevation, and in which an ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer has been used

Exclusion Criteria:

Patients do not have to meet any exclusion criteria

  • Patients treated percutaneously with any type of stent other than the SupraFlex Cruz® in the 6 months prior to the index procedure in which he or she is included.
  • Use in the same procedure or in a scheduled procedure of other stents different from the one evaluated for the treatment of another vessel(s).
  • Patients treatment for restenosis or stent thrombosis.
  • Patients presentation in cardiogenic shock or after cardiorespiratory arrest.
  • Patients with allergy to any of the components of the stent to be used.
  • Patients with impossibility for follow-up.
  • Patients with life expectancy less than 1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Supraflex Cruz Sirolimus-eluting Stent
Device: Supraflex Cruz Sirolimus-eluting Stent
PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NACE (Net Adverse Clinical Events)
Time Frame: 12 month
Combined endpoint of Cardiac Death, Acute Myocardial Infarction, Stroke, Need for new Treated Vessel Revascularization (TVR) and BARC (Bleeding Academic Research Consortium) 3-5
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE (Major Adverse Cardiac Events)
Time Frame: 12 months
To assess the occurrence of major adverse cardiac events (MACE) in patients receiving chronic oral anticoagulation who have been treated with ultrathin strut Sirolimus-eluting stents with bioabsorbable polymer.
12 months
MACE (Major Adverse Cardiac Events)
Time Frame: 6 months
To assess the occurrence of major adverse cardiac events (MACE) in patients receiving chronic oral anticoagulation who have been treated with ultrathin strut Sirolimus-eluting stents with bioabsorbable polymer.
6 months
TLF (Target Lesion Failure)
Time Frame: 12 months
To assess the failure rate of the lesion treated (TLF) with ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer in patients receiving chronic oral anticoagulation.
12 months
TLF (Target Lesion Failure)
Time Frame: 6 months
To assess the failure rate of the lesion treated (TLF) with ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer in patients receiving chronic oral anticoagulation.
6 months
Death
Time Frame: 12 months
To assess the occurrence of Death
12 months
Death
Time Frame: 6 months
To assess the occurrence of Death
6 months
Acute Myocardial Infarction (AMI)
Time Frame: 12 months
To assess the occurrence of AMI
12 months
Acute Myocardial Infarction (AMI)
Time Frame: 6 months
To assess the occurrence of AMI
6 months
Stroke
Time Frame: 12 months
To assess the occurrence of Stroke
12 months
Stroke
Time Frame: 6 months
To assess the occurrence of Stroke
6 months
Target vessel revascularization (TVR)
Time Frame: 12 months
To assess the occurrence of TVR
12 months
Target vessel revascularization (TVR)
Time Frame: 6 months
To assess the occurrence of TVR
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rEPIC13-ACO-FLEX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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