Status:
COMPLETED
Vascular Implant Safety and Efficacy Study
Lead Sponsor:
Biotronik CRC Inc.
Collaborating Sponsors:
Biotronik AG
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions
Eligibility Criteria
Inclusion
- Subject is \> 18 years and \< 85 years old
- Written subject informed consent
- Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients
- Subject is eligible for percutaneous coronary intervention (PCI)
- Subject is acceptable candidate for coronary artery bypass surgery
- Subject is eligible for Dual Anti Platelet Therapy (DAPT)
- Subjects with a maximum of two single discrete de novo lesions in two separate native coronary arteries that can be treated with the study stent during the index procedure
- Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation.
- Target lesion length up to 22 mm by visual estimation.
- Target lesion with ≥ 50% and \< 100% stenosis by visual estimation
Exclusion
- Left main coronary artery disease
- Three-vessel coronary artery disease at the time of index procedure
- Angiographic evidence of thrombus in target vessel
- Chronic total occlusion
- Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon
- Bifurcation lesion requiring side branch intervention, if side branches \> 2mm in diameter are involved
- Ostial lesions (within 5 mm of vessel origin)
- In-stent restenosis
- Lesions with prior treatment with a drug coated balloon (DCB)
- Target lesion is located in or supplied by an arterial or venous bypass graft
- Target lesion requires treatment with. rotational atherectomy
- Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
- Previous treatment of target vessel within 9 months of index-procedure
- Patients with cardiogenic shock
- Documented left ventricular ejection fraction (LVEF) ≤ 30%
- Impaired renal function (serum creatinine \> 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
- Hemodynamically unstable NSTEMI or STEMI within 72 hours prior to index procedure
- Cerebrovascular event (within 3 months of index procedure)
- Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids are allowed) or has known life-limiting immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, but not diabetes mellitus)
- Known allergies to: Acetylsalicylic Acid (ASA), heparin, contrast medium, sirolimus, or similar drugs, exipients or the stent material
- Triple anticoagulation therapy
- Life expectancy less than 1 year
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- Inability to understand or read the informed consent form
- Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
- In the investigators opinion subjects will not be able to comply with the follow-up requirements
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2020
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03263858
Start Date
August 14 2017
End Date
January 28 2020
Last Update
July 10 2020
Active Locations (5)
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1
University Hospital Bern
Bern, Switzerland
2
Hôpiteaux Universitaires Genève (HUG)
Geneva, Switzerland
3
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
4
Cardiocentro Ticino
Lugano, Switzerland