Health TrialsbyHealthPanel

SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

ConditionsCoronary Artery Disease (CAD)Ischemic Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years old and;

Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for use

Patients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries.

Substudy: Patients with Ejection Fraction <45% by Echocardiography

Disqualifiers

Not meet inclusion criteria

Contraindication for antiplatelet treatment

Patient life expectancy less than 12 months

Trial population

Patients treated with MULTIFLEX PMCF according to routine hospital practice and following instructions for use

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • SUPRAFLEX CRUZ

    Device

    Patients in whom treatment with SUPRAFLEX CRUZ has been attempted

Treatment groups

508 Participants
are divided into 1 treatment group
Group A: Coronary Artery Disease (CAD)1 intervention

Trial outcomes

Primary outcomes

1

Target Lesion Failure (TLF)

Rate of target lesion failure

Time frame
12 months
2

Device-oriented Composite Endpoint (DoCE)

Device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel myocardial infarction, clinically indicated repeat revascularization of the target lesion at 12 months

Time frame
12 months

Secondary outcomes

1

Major Adverse Cardiovascular Event (MACE)

Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke

Time frame
12 months
2

Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography

In the subgroup of patients with reduced Ejection Fraction, Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography

Time frame
1 month
3

Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography

In the subgroup of patients with reduced Ejection Fraction, Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography

Time frame
1 month
4

Change of segmental movement of the territory revascularized measured by echocardiography

In the subgroup of patients with reduced Ejection Fraction, Change from baseline segmental movement of the territory revascularized measured by echocardiography

Time frame
1 month

Other outcomes

Sponsors and contacts

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

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
Apply now