Evaluation of the Vivo Isar Stent System in Routine Clinical Practice
ConditionArtery Coronary Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTranslumina GmbH
About this trial
The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Ability to provide signed informed consent form.
Male or non-pregnant female patient (Pregnancy status to be confirmed verbally from the female patient of reproductive age)
Presentation with acute coronary syndrome or chronic coronary syndrome with stable angina or angina equivalent symptoms or with a positive noninvasive test for ischemia or evidence of a functionally significant coronary stenosis.
Disqualifiers
Concurrent participation in another clinical trial.
Having benefited from an angioplasty of ≤ 1 month with a stent other than Vivo ISAR.
Planned elective surgery in next 6 months
Cardiogenic shock/ hemodynamically unstable patients
Trial population
all-comers population who qualify for percutaneous coronary intervention (consisting of patients with symptomatic coronary artery disease including chronic coronary syndromes (CCS) and ACS) of any gender, ≥ 18 years old
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Percutaneous Coronary Intervention
DeviceThe Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
rate of target lesion failure
• The rate of target lesion failure at 12 months follow-up defined as the composite endpoint of: * Cardiac death * Myocardial infarction related to the target vessel * Clinically documented target lesion revascularization
Time frame
12 months post-procedureSecondary outcomes
1
Device success rate
• Device success rate defined as successful placement and deployment of the device at the target lesion site with successful removal of the delivery system leaving a final residual stenosis \<30% of the segment of the culprit lesion covered by the stent at 1 year
Time frame
12 months post-procedure2
Procedural success rate
* Procedural success rate defined as device success without major ischemia-related adverse cardiac events during hospitalization and up to a maximum of 7 days post-procedure : * Cardiac death * Any MI * Target-vessel MI
Time frame
7 days post-procedure3
Assess reperfusion
Target Lesion Revascularization at 12 months
Time frame
12 months post-procedure4
• Evaluate the antiplatelet treatment
antiplatelet consumption during 1 year after the procedure
Time frame
12 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Translumina GmbH
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov