The Direct III Post Market Study

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02693158
• Lead Sponsor: Svelte Medical Systems, Inc.

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-26
• Study Start: 2016-09
• Primary Completion: 2019-01
• Study Completion: 2020-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Event (MACE)	Discharge, 1, 6 and 12 months	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.
Target Vessel Failure (TVF)	Discharge, 1, 6 and 12 months	composite endpoint of Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods.

Trial Locations

Locations (8)

Meander Medical Center; 🇳🇱 Amersfoort, Netherlands

OLVG; 🇳🇱 Amsterdam, Netherlands

Tergooi Hospital; 🇳🇱 Blaricum, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

St Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands

HagaZiekenhuis; 🇳🇱 The Hague, Netherlands

University Medical Center; 🇳🇱 Utrecht, Netherlands

Albert Schweitzer Hospital; 🇳🇱 Dordrecht, Netherlands