A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)

May 8, 2024 updated by: Translumina Therapeutics LLP

A Prospective, Open-Label, Multi-Country, Multicentre, Observational PoSt Market SurvEillance of VIVO ISAR (Polymer-Free Sirolimus Eluting Coronary Stent System) In Real World Patients Undergoing PCI With Short Dual Antiplatelet Therapy

The objective of this post marketing observational registry is to evaluate clinical outcomes (safety and performance) in an all-comers population with coronary artery disease (CAD) treated with the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR and planned for an abbreviated (≤ 3 months) dual antiplatelet therapy (DAPT) regimen.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is a prospective, observational, multi-country, multi-Centre, single-arm registry designed to evaluate the clinical safety and performance of VIVO ISAR, Polymer Free Sirolimus Eluting Coronary Stent System. The study population is made up of subjects who have undergone PCI using VIVO ISAR and are receiving standard of care short DAPT treatment (≤ 3 months) . Subjects will be screened by site teams and offered the opportunity to participate in the registry after their procedure. Rationale for this study is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent in real world CAD patients with follow-up at 1 month, 3 months and 12 months.

All medications and procedures to be used/ performed in this registry are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.

The study does not influence the choice of device utilized nor does it alter the routine standard of care. After a patient has been treated with the Vivo ISAR, informed consent will be requested and the eligible patient will be registered in the study.

Baseline data will be completed using medical notes. All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days, 3 months and 12 months from the baseline PCI procedure date.

The 30 day, 3 months and 12 month telephonic follow up will consist of a verbally report of the DAPT anticoagulation medications continued, about any lab assessments that might have happened, recording of any adverse events, and any interventional treatment that has occurred since previous contact.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A real-world population undergoing percutaneous coronary intervention with VIVO-ISAR (Polymer Free Sirolimus Eluting Coronary Stent) and intended for treatment with ≤ 3 months of DAPT

Description

Inclusion Criteria:

  1. Ability to provide written informed consent.
  2. Treated only with the VIVO ISAR stent system.
  3. ≥ 18 years old.
  4. Male or non-pregnant female patient.
  5. Intended for treatment with ≤ 3 months DAPT after PCI as per standard of care.

Exclusion Criteria:

  1. Patients having any of the following conditions will not be considered (enrolled) for the study Concurrent participation in an interventional study.
  2. Cardiogenic shock/hemodynamic instability around the time of the index procedure.
  3. Concurrent medical condition with a life expectancy of less than 12 months.
  4. Allergy or contraindication to antiplatelet therapy, cobalt chromium, sirolimus or any known hypersensitivity to the planned anti-platelet drugs.
  5. History of cerebrovascular accident in the last 6 months.
  6. Pregnant female.
  7. PCI performed within the previous 3 months from the date of index procedure
  8. Treated with another stent type during the index procedure in addition to the VIVO ISAR stent system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic endpoint
Time Frame: 12 months
Cardiovascular death, myocardial infarction (not clearly attributable to a non-target vessel), definite or probable stent thrombosis or urgent target lesion revascularization (TLR).
12 months
Bleeding endpoint
Time Frame: 12 months
bleeding defined as Bleeding Academic Research Consortium (BARC) class 3 or higher
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 12 months
Mortality
12 months
Cardiovascular death
Time Frame: 12 months
  • Any death due to proximate cardiac cause (e.g., myocardial infarction, low-output failure, fatal arrhythmia).
  • Unwitnessed death and death of unknown cause.
  • All procedure-related deaths (including those related to concomitant treatment).
12 months
Myocardial infarction (MI)
Time Frame: 12 months

Myocardial Infarction (including periprocedural myocardial infarction) as defined per the Fourth Universal Definition of Myocardial Infarction: "Detection of a rise and/or fall of cardiac troponin (cTn) with at least one value above the 99th percentile and with at least one of the following:

  1. Symptoms of acute myocardial ischemia;
  2. New ischemic electrocardiographic (ECG) changes;
  3. Development of pathological Q waves;
  4. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology;
  5. Identification of a coronary thrombus by angiography including intracoronary imaging or by autopsy."
12 months
Stroke
Time Frame: 12 months
caused either by a clot obstructing the flow of blood to the brain (called an ischemic stroke) or by a blood vessel rupturing and preventing blood flow to the brain (called a hemorrhagic stroke)
12 months
Stent thrombosis (definite/probable)
Time Frame: 12 months

Definite Stent Thrombosis:

Angiographic confirmation of stent thrombosis:

  • The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent and presence of at least one of the following criteria within a 48-hour time window:
  • Acute onset of ischemic symptoms at rest
  • New ischemic ECG changes that suggest acute ischemia

  • Typical rise and fall in cardiac biomarkers

    b) Probable Stent Thrombosis Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:

  • Any unexplained death within the first 30 days.
  • Irrespective of the time after the index procedure, any MI that is related to documented ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
12 months
Target Lesion Revascularisation (TLR) - Ischemia driven (ID)
Time Frame: 12 months

A TLR is considered ischemia-driven if angiography at follow-up shows a percent diameter stenosis ≥50% and if one of the following occurs:

  • Positive history of recurrent angina pectoris, presumably related to the target vessel.
  • Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel.
  • Abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve).
  • A target lesion revascularisation (TLR) or target vessel revascularisation (TVR) with a diameter stenosis ≥70% even in the absence of the above-mentioned ischemic signs or symptoms TLR events which do not meet the criteria for ID-TLR are considered non-ID TLR events
12 months
Urgent TLR
Time Frame: 12 months
Acute condition post index procedure where urgent revascularization of the target lesion is necessary
12 months
Target vessel revascularisation (TVR)
Time Frame: 12 months
repeat percutaneous intervention or surgical bypass of any segment of a target vessel.
12 months
BARC class 2 bleeding
Time Frame: 12 months
any overt, actionable sign of hemorrhage
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translumina Therapeutics LLP

Collaborators

Iqvia Pty Ltd

Investigators

  • Study Chair: Prof Adnan Kastrati, German Heart Centre Munich, Germany
  • Principal Investigator: Prof Azfar Zaman, Freeman Hospital, Newcastle, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TL/SECURE/VIVO/2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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