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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02693158
Other study ID # IP-15-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date January 2020

Study information

Verified date June 2020
Source Svelte Medical Systems, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date January 2020
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Meander Medical Center Amersfoort
Netherlands OLVG Amsterdam
Netherlands Tergooi Hospital Blaricum
Netherlands Amphia Ziekenhuis Breda
Netherlands Albert Schweitzer Hospital Dordrecht
Netherlands St Antonius Hospital Nieuwegein
Netherlands HagaZiekenhuis The Hague
Netherlands University Medical Center Utrecht

Sponsors (1)

Lead Sponsor Collaborator
Svelte Medical Systems, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Target Vessel Failure (TVF) composite endpoint of Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods. Discharge, 1, 6 and 12 months
Secondary 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. Discharge, 1, 6 and 12 months
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