Coronary Artery DiseaseNCT03052530
Sapphire II PRO US Clinical Study
A study testing Sapphire II PRO in people with Coronary Artery Disease and Coronary Disease, run by OrbusNeich at 4 sites in United States.
Trial summary
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
- What is being tested?
- Sapphire II PRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 May 2017to 24 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Clinical Inclusion Criteria:
- Subject is ≥ 18 years of age.
- Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
- Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.
- Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia. Angiographic Inclusion Criteria
- Subject must have de novo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. An embolic protection device must be used in all Saphenous venous grafts (SVG) interventions performed during the index procedure.
- A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
- Target and non-target lesions must be located in different coronary arteries or bypass grafts.
- Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO)
- Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success.
Clinical Exclusion Criteria:
- Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
- Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure.
- Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
- Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
- A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
- Cerebrovascular accident (CVA) within the past 6 months.
- Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
- Subject has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary) Angiographic Exclusion Criteria
- More than two lesions requiring treatment.
- Unprotected left main coronary artery disease.(Greater than 50% diameter stenosis)
- Coronary artery spasm of the target vessel in the absence of a significant stenosis.
- Target lesion with angiographic presence of probable or definite thrombus.
- Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter.
- Non-target lesion to be treated during the index procedure meets any of the following criteria:
- Located within a bypass graft (venous or arterial)
- Left main location
- Chronic total occlusion
- Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
- Treatment not deemed a clinical angiographic success
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
The Christ Hospital Heart and Vascular
Cincinnati, Ohio, 45219
University of Miami
Miami, Florida, 33146
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
About this study
Official title: Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention.
Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
- Being tested
- Sapphire II PRO
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sapphire II PRODevice
To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters.
| Study group | Role | What they receive |
|---|---|---|
| Sapphire II PRO | Experimental | Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters Receives: Device: Sapphire II PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device Procedural Success
Device procedural success consisting of the following:
- Successful delivery, inflation, deflation and withdrawal of the study balloon
- No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon
- Final TIMI flow grade of 3 at the conclusion of the PCI procedure
Measured: Peri-procedural (at Day 0)
Secondary outcomes (3)
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
In-hospital Major Adverse Cardiac Events (MACE)
- All death (cardiac and non-cardiac)
- Myocardial infarction (MI)
- Target Lesion Revascularization (TLR)
Measured: Endpoints will be measured through hospital discharge (expected to be within 24 hours)
Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel
In-hospital stent thrombosis (ST) within the target vessel
Measured: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
Clinically Significant Arrhythmias (requiring intervention)
Measured: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start5 May 2017
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrbusNeich
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- David Kandzari, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052530
- Sponsor's protocol ID
- VP-0714
- Status last verified
- Apr 2018
- First submitted
- 7 Feb 2017
- Last updated
- 11 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.
- ClinicalTrials.gov ID
- NCT03052530
- Acronym / sponsor ID
- VP-0714
- Conditions
- Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- OrbusNeichIndustry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 5 May 2017 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Posted 4 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention.
Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sapphire II PRO | Experimental | Device: Sapphire II PROSingle arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Sapphire II PROTo pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters. | Device | Sapphire II PRO |
Primary outcome
Number of Participants With Device Procedural Success
Time frame: Peri-procedural (at Day 0)
Device procedural success consisting of the following: * Successful delivery, inflation, deflation and withdrawal of the study balloon * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon * Final TIMI flow grade of 3 at the conclusion of the PCI procedure
3 secondary outcomes
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
Time frame: Endpoints will be measured through hospital discharge (expected to be within 24 hours)
Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel
Time frame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
Time frame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David Kandzari, MD principal investigator
Piedmont Heart Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sapphire II PRO in people with Coronary Artery Disease and Coronary Disease, run by OrbusNeich at 4 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?
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: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 4 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Device Procedural Success (time frame: Peri-procedural (at Day 0)). 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 11 May 2018.