Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 26
- Primary Endpoint
- Efficacy Endpoint. Freedom fromTarget Lesion Failure
Study Overview
Brief Summary
International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.
Detailed Description
The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Coroflex® ISAR NEO is intended to be used for
- Patients must be at least 18 years of age AND
- The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND
- Patients with Novo lesion length 2-4 mm AND
- Informed consent signed
Exclusion Criteria
- Patients with express refusal by the patient to participate in the study.
- Patients pregnant women and lactating women.
- Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
- Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated
- Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
- Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
- Patients with known sensitivity to contrast agents who cannot be premedicated.
- Patients with contraindications or hypersensitivity to sirolimus
- Patients with a life expectancy of less than 2 years
- Patients included in other clinical trials
Arms & Interventions
Coronary Artery Disease (CAD)
Intervention: Coroflex® ISAR NEO coronary stent system (Device)
Coronary Artery Disease (CAD) and high risk of bleeding
Intervention: Coroflex® ISAR NEO coronary stent system (Device)
Outcomes
Primary Outcomes
Efficacy Endpoint. Freedom fromTarget Lesion Failure
Time Frame: 7 days
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Safety Endpoint. Freedom from Target Lesion Failure
Time Frame: 7 days
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR)
Secondary Outcomes
- Freedom from Coronary thrombosis(During PCI)
- Freedom from Balloon rupture(During PCI)
- Freedom from Hypotube rupture(During PCI)
- Freedom from Accidental dislodgement of the stent(During percutaneous coronary intervention (PCI))
- Freedom from Complicated withdrawal(During PCI)
- Freedom from Coronary dissection >C(During PCI)
- Freedom from Coronary perforation(During PCI)
- Freedom from No reflow(During PCI)
Investigators
Study Sites (26)
Identifiers
- NCT ID
- NCT05698732
- Other Study IDs
- Coroflex® ISAR NEO PMCF Study
Dates
- First Submitted
- (3 years ago)
- First Posted
- (3 years ago)
- Primary Completion
- (in 4 months)
- Study Completion
- (in 4 months)
- Last Verified
- (29 days ago)
- Last updated
- (19 days ago)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- Has Results
- No