The Direct III Post Market Study

Svelte Medical Systems, Inc.440 enrolled

Overview

The primary objective of this multicenter, single-arm, observational study is to evaluate the feasibility of a systematic direct stenting strategy with the Svelte SLENDER IDS Sirolimus-Eluting Coronary Stent-on-a-Wire Integrated Delivery System (SLENDER IDS) in an all-comers, real-world population.

In this post-market study, the population will include real-world subjects who are intended to be treated, with SLENDER IDS as standard therapy. Follow-up contacts post procedure will be made for clinical assessments at hospital discharge, 1, 6 and 12 months. This study is designed as a prospective, multi-center, single-arm, observational all-comers clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the feasibility of a direct stenting strategy in an all-comers population. A minimum of two hundred fifty (250) subjects will be treated at up to 20 sites in Europe. Review of safety data and risks to subjects will be monitored by an independent Clinical Events Committee (CEC) at pre-specified enrollment milestones.

Study Type

OBSERVATIONAL

Enrollment

440

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is ≥ 18 years old; 2. Subject has symptomatic heart disease due to coronary artery lesions of length \< 28 mm and a reference vessel diameter 2.5 - 4.0 mm. 3. Subject is intended to be treated with PCI and implantation of SLENDER IDS as part of his/her standard treatment 4. Subject or subject's legal representative understands the study requirements and the treatment procedures and provides written informed consent before any study specific tests or procedures are performed. Exclusion Criteria: 1. Subject is unable to receive anti-platelet and/or anti-coagulant therapy; 2. Subject is allergic to sirolimus, PEA III Ac Bz, cobalt, chromium, nickel or tungsten; 3. The subject is judged to have lesions preventing complete inflation of an angioplasty balloon or proper placement of a coronary stent, including chronic total occlusions. 4. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential, based on the standard of care for the cath lab); 5. Subject is participating in another investigational drug or device clinical trial that the investigator feels would interfere with the subject's participation in this study.

Locations (8)

Meander Medical Center

Amersfoort, Netherlands

OLVG

Amsterdam, Netherlands

Tergooi Hospital

Blaricum, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Outcomes

Primary Outcomes

Target Lesion Failure (TLF)

Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.

Time frame: 12 months

Secondary Outcomes

Target Vessel Failure (TVF)

composite endpoint of Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods.

Time frame: Discharge, 1, 6 and 12 months

Major Adverse Cardiac Event (MACE)

defined as a composite of all deaths, Target Vessel MI (Q wave and non-Q wave), emergent coronary artery bypass grafting surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods.

Time frame: Discharge, 1, 6 and 12 months

Data from ClinicalTrials.gov

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