Acute Coronary SyndromeNCT03716102
OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
A study testing PCI with implantation with DES in people with Acute Coronary Syndrome, run by Svelte Medical Systems, Inc. at 2 sites in United States.
Trial summary
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- PCI with implantation with DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2018to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northern Michigan Hospital d.b.a McLaren Northern Michigan
Petoskey, Michigan, 49770
Scottsdale Healthcare
Scottsdale, Arizona, 85258
About this study
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
Read the detailed description
This is a prospective, open, non-randomized, study involving two (2) centers in the United States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
- Conditions
- Acute Coronary Syndrome
- Being tested
- PCI with implantation with DES
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI with implantation with DESDevice
PCI with implantation with DES
| Study group | Role | What they receive |
|---|---|---|
| Svelte DES | Experimental | Stent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug Receives: Device: PCI with implantation with DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed blood concentration (Cmax)
Measured: Up to 30 days
Time to reach maximum blood concentration (tmax)
Measured: Up to 30 days
Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t)
Measured: Up to 30 days
Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞)
Measured: Up to 30 days
Terminal phase half-life (t1/2)
Measured: Up to 30 days
Apparent total blood clearance (CL/F)
Measured: Up to 30 days
Apparent volume of distribution (Vd/F)
Measured: Up to 30 days
Secondary outcomes (1)
Target Vessel Failure (TVF)
Measured: 6 months, 12 months, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start21 Nov 2018
- Primary completion15 Jun 2020
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Svelte Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Donohoe, MD, Study director, Svelte Medical Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716102
- Sponsor's protocol ID
- IP-18-001
- Status last verified
- Jun 2020
- First submitted
- 18 Oct 2018
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIZE Sirolimus-Eluting Coronary Stent Systems Pharmacokinetics (PK) Study
- ClinicalTrials.gov ID
- NCT03716102
- Acronym / sponsor ID
- IP-18-001
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Svelte Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
Detailed description
This is a prospective, open, non-randomized, study involving two (2) centers in the United States. A minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the Svelte DES.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Svelte DES | Experimental | Device: PCI with implantation with DESStent: A mounted Cobalt Chromium (Co-Cr) alloy based stent Polymer coating: Polyesteramide (PEA) Sirolimus drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI with implantation with DESPCI with implantation with DES | Device | Svelte DES |
Primary outcome
Maximum observed blood concentration (Cmax)
Time frame: Up to 30 days
Time to reach maximum blood concentration (tmax)
Time frame: Up to 30 days
Area under the blood concentration versus time curve: time zero to the final quantifiable concentration) (AUC 0-t)
Time frame: Up to 30 days
Area under the blood concentration versus time curve: time zero to the extrapolated infinite time (AUC 0-∞)
Time frame: Up to 30 days
Terminal phase half-life (t1/2)
Time frame: Up to 30 days
Apparent total blood clearance (CL/F)
Time frame: Up to 30 days
Apparent volume of distribution (Vd/F)
Time frame: Up to 30 days
1 secondary outcome
Target Vessel Failure (TVF)
Time frame: 6 months, 12 months, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Donohoe, MD study director
Svelte Medical Systems
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI with implantation with DES in people with Acute Coronary Syndrome, run by Svelte Medical Systems, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed blood concentration (Cmax) (time frame: Up to 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.