Vascular Implant Safety and Efficacy Study

NCT03263858 | Completed DMC

• 1 other identifier: C1606
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 5

Brief Summary

Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Strut coverage cohort 1

  Strut coverage will be assessed by OCT analysis

  1 month

• In stent late lumen loss cohort 2

  Late lumen loss with will be assessed by central QCA assessment

  9 months

Study Arms (1)

Cohort 1 and 2

EXPERIMENTAL

Device: Stent

Interventions

Stent DEVICE

Implantation of coronary stent in de novo coronary artery lesions

Cohort 1 and 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Biotronik CRC Inc.: lead
• Biotronik AG: collaborator

Study Sites (5)

University Hospital Bern

Bern, Switzerland

Location

Hôpiteaux Universitaires Genève (HUG)

Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Switzerland

Location

Cardiocentro Ticino

Lugano, Switzerland

Location

University Hospital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 28, 2017
• Study Start: August 14, 2017
• Primary Completion: November 4, 2019
• Study Completion: January 28, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)