Clinical trial NCT06412250: A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Translumina Therapeutics LLP
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2024-05-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ischemic endpoint
timeFrame: 12 months
measure: Bleeding endpoint
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 12 months
measure: Cardiovascular death
timeFrame: 12 months
measure: Myocardial infarction (MI)
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: Stent thrombosis (definite/probable)
timeFrame: 12 months
measure: Target Lesion Revascularisation (TLR) - Ischemia driven (ID)
timeFrame: 12 months
measure: Urgent TLR
timeFrame: 12 months
measure: Target vessel revascularisation (TVR)
timeFrame: 12 months
measure: BARC class 2 bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Zydus Hospitals
city: Bangalore
country: India
facility: Fortis Hospital
city: Bhatinda
country: India
facility: Adesh Hospital
city: Chandigarh
country: India
facility: PGIMER
city: Delhi
country: India
facility: National Heart Institute
city: Delhi
country: India
facility: Fortis Escorts Heart Institute & Research Centre
city: Delhi
country: India
facility: Fortis Escorts Heart Institute & Research Centre
city: Gurugram
country: India
facility: Medanta-The Medicity
city: Hyderabad
country: India
facility: Yashoda Hospitals
city: Jabalpur
country: India
facility: Shalby Hospital
city: Kalyan
country: India
facility: Fortis Hospital
city: Kanpur
country: India
facility: L.P.S Institute of Cardiology
city: Kolkata
country: India
facility: Fortis Hospital
city: Lucknow
country: India
facility: Dr. Ram Manohar Lohia Hospital (RML)
city: Miraj
country: India
facility: Seva Sadan Hospital
city: Mohali
country: India
facility: Fortis
city: Somajiguda
country: India
facility: Yashodha Hospital
city: Campobasso
country: Italy
facility: ASREM - Regional Hospitals
city: Mercogliano AV
country: Italy
facility: Montevergine
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Roma
country: Italy
facility: Tor Vergata University
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC (University Medical Centers)
city: Hilversum
country: Netherlands
facility: Tergooi MC
city: Venlo
country: Netherlands
facility: Viecuri MC
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury NHS Foundation Trust
city: Wigan
country: United Kingdom
facility: Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: German Heart Centre Munich, Germany
name: Prof Adnan Kastrati
role: STUDY_CHAIR
affiliation: Freeman Hospital, Newcastle, UK
name: Prof Azfar Zaman
role: PRINCIPAL_INVESTIGATOR
References: