NCT03716102Active, not recruiting
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
Source: ClinicalTrials.gov · Last updated 26 Jun 2020
Brief summary (registry, in English)
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 18 Oct 2018
- Start date
- 21 Nov 2018
- Primary completion date
- 15 Jun 2020
- Lead sponsor
- Svelte Medical Systems, Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT03716102
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 21 Nov 2018 to the primary completion date, 15 Jun 2020
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina
Other
- Subject's target lesion(s) is located in the left main coronary artery
- Subject's target lesion(s) is located within 3mm of the origin of the LAD or LCX coronary artery
- Subject's target lesion(s) is located within a SVG or an arterial graft
- Subject's target lesion(s) will be accessed via SVG or arterial graft
Who the study is looking for
- Subject is an eligible candidate for PCI
- Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
- Subject is an acceptable candidate for CABG
- Subject has ≤ 3 de novo target lesions in ≤ 2 native coronary artery vessels, with ≤ 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria
- Target lesion(s) must be located in a native coronary artery with RVD ≥ 2.25mm and ≤ 4.00mm
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northern Michigan Hospital d.b.a McLaren Northern Michigan Coordinator of this site? Confirm its status | Petoskey | United States | Unknown status |
| Scottsdale Healthcare Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.