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NCT Number: NCT06863155

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario de Albacete, Albacete, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supraflex Cruz Sirolimus-eluting Stent

Device

PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Death

    Time frame: 12 months

    To assess the occurrence of Death

  6. Death

    Time frame: 6 months

    To assess the occurrence of Death

  7. Acute Myocardial Infarction (AMI)

    Time frame: 12 months

    To assess the occurrence of AMI

  8. Acute Myocardial Infarction (AMI)

    Time frame: 6 months

    To assess the occurrence of AMI

  9. Stroke

    Time frame: 12 months

    To assess the occurrence of Stroke

  10. Stroke

    Time frame: 6 months

    To assess the occurrence of Stroke

  11. Target vessel revascularization (TVR)

    Time frame: 12 months

    To assess the occurrence of TVR

  12. Target vessel revascularization (TVR)

    Time frame: 6 months

    To assess the occurrence of TVR

Study contacts

Contact information is provided by the study sponsor or research team.

FUNDACION EPIC

CONTACT

[email protected]

0034987876135

Juan Gabriel Córdoba Soriano, MD, PhD

CONTACT

[email protected]

0034 967597532

Sponsors and collaborators

Lead sponsor

Fundación EPIC

Other

Registry information

Acronym: ACO_FLEX

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Mar 7, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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