The Direct III Post Market Study

NCT02693158 | Completed

• 1 other identifier: IP-15-002
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 8

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Target Vessel Failure (TVF)

  Discharge, 1, 6 and 12 months

• Major Adverse Cardiac Event (MACE)

  Discharge, 1, 6 and 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Subject is ≥ 18 years old;
• Subject has symptomatic heart disease due to coronary artery lesions of length \< 28 mm and a reference vessel diameter 2.5 - 4.0 mm.
• Subject is intended to be treated with PCI and implantation of SLENDER IDS as part of his/her standard treatment
• 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.

You may not qualify if:

• Subject is unable to receive anti-platelet and/or anti-coagulant therapy;
• Subject is allergic to sirolimus, PEA III Ac Bz, cobalt, chromium, nickel or tungsten;
• 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.
• 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);
• 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.

Sponsors & Collaborators

• Svelte Medical Systems, Inc.: lead

Study Sites (8)

Meander Medical Center

Amersfoort, Netherlands

Location

OLVG

Amsterdam, 1091 AC, Netherlands

Location

Tergooi Hospital

Blaricum, 1261AN, Netherlands

Location

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Albert Schweitzer Hospital

Dordrecht, 3300 AK, Netherlands

Location

St Antonius Hospital

Nieuwegein, 3430 EM, Netherlands

Location

HagaZiekenhuis

The Hague, 2545 AA, Netherlands

Location

University Medical Center

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Dennis Donohoe, MD

  Svelte Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 26, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

NL (8)