Coronary Artery DiseaseACO_FLEXNCT06863155
Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 13 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease
- What is being tested?
- Supraflex Cruz Sirolimus-eluting Stent
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 500 participants
- Where
- 13 sitesSpain
- Study dates
- 6 May 2025to 31 Mar 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients under chronic oral anticoagulation undergoing PCI with implantation of a SupraFlex Cruz(r) stent
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Spain13 sites, 13 recruiting
- Recruiting
Hospital General Universitario de Albacete
Albacete, 02008
- Recruiting
Hospital Universitario San Juan de Alicante
Alicante, 03550
- Recruiting
Hospital General Universitario de Merida
Badajoz, 6800
- Recruiting
Hospital General Universitari de Castelló
Castelló, 12004
- Recruiting
H.G.U. de Ciudad Real.
Ciudad Real, 13005
- Recruiting
Hospital General Universitari d'Elx
Elche, 03203
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
- Recruiting
Hospital Universitario de Canarias
Laguna, 38320
- Recruiting
Hospital Doctor Jose Molina Orosa
Las Palmas de Gran Canaria, 35500
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, 28222
- Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
- Recruiting
Hospital General de Fuerteventura
Puerto del Rosario, 35600
- Recruiting
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Being tested
- Supraflex Cruz Sirolimus-eluting Stent
- Keywords
- Chronic oral anticoagulation, Ultrathin-strut stent, Biodegradable polymer, High-bleeding risk, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraflex Cruz Sirolimus-eluting StentDevice
PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation.
| Study group | Role | What they receive |
|---|---|---|
| Supraflex Cruz Sirolimus-eluting Stent | Not described Receives: Device: Supraflex Cruz Sirolimus-eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
NACE (Net Adverse Clinical Events)
Combined endpoint of Cardiac Death, Acute Myocardial Infarction, Stroke, Need for new Treated Vessel Revascularization (TVR) and BARC (Bleeding Academic Research Consortium) 3-5
Measured: 12 month
Secondary outcomes (12)
MACE (Major Adverse Cardiac Events)
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.
Measured: 12 months
MACE (Major Adverse Cardiac Events)
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.
Measured: 6 months
TLF (Target Lesion Failure)
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.
Measured: 12 months
TLF (Target Lesion Failure)
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.
Measured: 6 months
Death
To assess the occurrence of Death
Measured: 12 months
Death
To assess the occurrence of Death
Measured: 6 months
Acute Myocardial Infarction (AMI)
To assess the occurrence of AMI
Measured: 12 months
Acute Myocardial Infarction (AMI)
To assess the occurrence of AMI
Measured: 6 months
Stroke
To assess the occurrence of Stroke
Measured: 12 months
Stroke
To assess the occurrence of Stroke
Measured: 6 months
Target vessel revascularization (TVR)
To assess the occurrence of TVR
Measured: 12 months
Target vessel revascularization (TVR)
To assess the occurrence of TVR
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start6 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863155
- Sponsor's protocol ID
- rEPIC13-ACO-FLEX
- Acronym
- ACO_FLEX
- Status last verified
- Aug 2026
- First submitted
- 3 Mar 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lemos PA, Chandwani P, Saxena S, Ramachandran PK, Abhyankar A, Campos CM, Marchini JF, Galon MZ, Verma P, Sandhu MS, Parikh N, Bhupali A, Jain S, Prajapati J. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry. BMJ Open. 2016 Feb 17;6(2):e010028. doi: 10.1136/bmjopen-2015-010028.
PubMed 26888727Choudhury A, Garg S, Smith J, Sharp A, Nabais de Araujo S, Chauhan A, Patel N, Wrigley B, Chattopadhyay S, Zaman AG. Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months' results from the S-FLEX UK registry. BMJ Open. 2019 Oct 11;9(10):e026578. doi: 10.1136/bmjopen-2018-026578.
PubMed 31604782Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019 Mar 9;393(10175):987-997. doi: 10.1016/S0140-6736(18)32467-X. Epub 2019 Feb 28.
PubMed 30827782Biscaglia S, Guiducci V, Escaned J, Moreno R, Lanzilotti V, Santarelli A, Cerrato E, Sacchetta G, Jurado-Roman A, Menozzi A, Amat Santos I, Diez Gil JL, Ruozzi M, Barbierato M, Fileti L, Picchi A, Lodolini V, Biondi-Zoccai G, Maietti E, Pavasini R, Cimaglia P, Tumscitz C, Erriquez A, Penzo C, Colaiori I, Pignatelli G, Casella G, Iannopollo G, Menozzi M, Varbella F, Caretta G, Dudek D, Barbato E, Tebaldi M, Campo G; FIRE Trial Investigators. Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction. N Engl J Med. 2023 Sep 7;389(10):889-898. doi: 10.1056/NEJMoa2300468. Epub 2023 Aug 26.
PubMed 37634150Paradies V, Maurina M, Tonino P, Hofma SH, Vos J, van Kuijk JP, Oemrawsingh RM, Mafragi AA, Spano F, Pisters R, Polad J, Ijsselmuiden S, Cambero MM, Smits PC. Comparison of Supraflex Cruz 60 mum Versus Ultimaster Tansei 80 mum Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial. Am J Cardiol. 2023 Nov 1;206:230-237. doi: 10.1016/j.amjcard.2023.08.046. Epub 2023 Sep 13.
PubMed 37708755
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
- ClinicalTrials.gov ID
- NCT06863155
- Acronym / sponsor ID
- ACO_FLEX / rEPIC13-ACO-FLEX
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Keywords
- Chronic oral anticoagulation, Ultrathin-strut stent, Biodegradable polymer, High-bleeding risk, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supraflex Cruz Sirolimus-eluting Stent | – | Device: Supraflex Cruz Sirolimus-eluting Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under chronic oral anticoagulation undergoing PCI with implantation of a SupraFlex Cruz(r) stent
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraflex Cruz Sirolimus-eluting StentPCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation. | Device | Supraflex Cruz Sirolimus-eluting Stent |
Primary outcome
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 secondary outcomes
MACE (Major Adverse Cardiac Events)
Time frame: 12 months
MACE (Major Adverse Cardiac Events)
Time frame: 6 months
TLF (Target Lesion Failure)
Time frame: 12 months
TLF (Target Lesion Failure)
Time frame: 6 months
Death
Time frame: 12 months
Death
Time frame: 6 months
Acute Myocardial Infarction (AMI)
Time frame: 12 months
Acute Myocardial Infarction (AMI)
Time frame: 6 months
Stroke
Time frame: 12 months
Stroke
Time frame: 6 months
Target vessel revascularization (TVR)
Time frame: 12 months
Target vessel revascularization (TVR)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 26888727Lemos PA, Chandwani P, Saxena S, Ramachandran PK, Abhyankar A, Campos CM, Marchini JF, Galon MZ, Verma P, Sandhu MS, Parikh N, Bhupali A, Jain S, Prajapati J. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry. BMJ Open. 2016 Feb 17;6(2):e010028. doi: 10.1136/bmjopen-2015-010028.
- Background: PubMed 31604782Choudhury A, Garg S, Smith J, Sharp A, Nabais de Araujo S, Chauhan A, Patel N, Wrigley B, Chattopadhyay S, Zaman AG. Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months' results from the S-FLEX UK registry. BMJ Open. 2019 Oct 11;9(10):e026578. doi: 10.1136/bmjopen-2018-026578.
- Background: PubMed 30827782Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019 Mar 9;393(10175):987-997. doi: 10.1016/S0140-6736(18)32467-X. Epub 2019 Feb 28.
- Background: PubMed 37634150Biscaglia S, Guiducci V, Escaned J, Moreno R, Lanzilotti V, Santarelli A, Cerrato E, Sacchetta G, Jurado-Roman A, Menozzi A, Amat Santos I, Diez Gil JL, Ruozzi M, Barbierato M, Fileti L, Picchi A, Lodolini V, Biondi-Zoccai G, Maietti E, Pavasini R, Cimaglia P, Tumscitz C, Erriquez A, Penzo C, Colaiori I, Pignatelli G, Casella G, Iannopollo G, Menozzi M, Varbella F, Caretta G, Dudek D, Barbato E, Tebaldi M, Campo G; FIRE Trial Investigators. Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction. N Engl J Med. 2023 Sep 7;389(10):889-898. doi: 10.1056/NEJMoa2300468. Epub 2023 Aug 26.
- Background: PubMed 37708755Paradies V, Maurina M, Tonino P, Hofma SH, Vos J, van Kuijk JP, Oemrawsingh RM, Mafragi AA, Spano F, Pisters R, Polad J, Ijsselmuiden S, Cambero MM, Smits PC. Comparison of Supraflex Cruz 60 mum Versus Ultimaster Tansei 80 mum Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial. Am J Cardiol. 2023 Nov 1;206:230-237. doi: 10.1016/j.amjcard.2023.08.046. Epub 2023 Sep 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 13 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Gabriel Córdoba Soriano, MD, PhD (0034 967597532, jgcordoba@foroepic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NACE (Net Adverse Clinical Events) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06863155, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.