Coronary Artery Disease Clinical Trial
— Direct IIIOfficial title:
Direct Implantation of Sirolimus-Eluting Stents With Bioresorbable Drug Carrier Technology Utilizing the Svelte Drug-Eluting Coronary Stent: The Direct III Post Market Study
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 |
Verified date | June 2020 |
Source | Svelte Medical Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Svelte Medical Systems, Inc. |
Netherlands,
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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