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

NCT06863155 | Recruiting

• 1 other identifier: rEPIC13-ACO-FLEX
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 11

Brief 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. 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

Ischemic Heart Disease; Coronary Artery Disease

Keywords

Chronic oral anticoagulation; Ultrathin-strut stent; Biodegradable polymer; High-bleeding risk; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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

  12 month

Secondary Outcomes (12)

• MACE (Major Adverse Cardiac Events)

  12 months

• MACE (Major Adverse Cardiac Events)

  6 months

• TLF (Target Lesion Failure)

  12 months

• TLF (Target Lesion Failure)

  6 months

• Death

  12 months

Study Arms (1)

Supraflex Cruz Sirolimus-eluting Stent

Device: Supraflex Cruz Sirolimus-eluting Stent

Interventions

Supraflex Cruz Sirolimus-eluting Stent DEVICE

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

Supraflex Cruz Sirolimus-eluting Stent

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (11)

Hospital General Universitario de Albacete

Albacete, 02008, Spain

RECRUITING

Hospital Universitario San Juan de Alicante

Alicante, 03550, Spain

RECRUITING

Hospital General Universitario de Merida

Badajoz, 6800, Spain

RECRUITING

Hospital General Universitari de Castelló

Castelló, 12004, Spain

RECRUITING

H.G.U. de Ciudad Real.

Ciudad Real, 13005, Spain

RECRUITING

Hospital General Universitari d'Elx

Elche, 03203, Spain

RECRUITING

Hospital Universitario de Canarias

Laguna, 38320, Spain

RECRUITING

Hospital Doctor Jose Molina Orosa

Las Palmas de Gran Canaria, 35500, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, 28222, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, 31008, Spain

RECRUITING

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 26888727 BACKGROUND

• Choudhury 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.

  PMID: 31604782 BACKGROUND

• Zaman 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.

  PMID: 30827782 BACKGROUND

• Biscaglia 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.

  PMID: 37634150 BACKGROUND

• Paradies 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.

  PMID: 37708755 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Juan Gabriel Córdoba Soriano, MD, PhD

CONTACT

0034 967597532; jgcordoba@foroepic.org

FUNDACION EPIC

CONTACT

0034987876135; iepic@fundacionepic.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2029
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

ES (11)