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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-06

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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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

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Coronary Artery Disease Ischemic Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Supraflex Cruz Sirolimus-eluting Stent

Intervention Type DEVICE

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

Interventions

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Supraflex Cruz Sirolimus-eluting Stent

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

Intervention Type DEVICE

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No