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

ConditionsCoronary Artery DiseaseIschemic Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Supraflex Cruz Sirolimus-eluting Stent

    Device

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Supraflex Cruz Sirolimus-eluting Stent1 intervention

Trial outcomes

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

Time frame
12 month

Secondary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
6 months
3

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.

Time frame
12 months
4

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
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