Coronary Artery DiseaseNCT03106961
OCT and Scaffold Embedding After NC Balloon
An observational study of Coronary Artery Disease, run by St. Francis Hospital, New York at 1 site in United States.
Trial summary
This study is a single-center, prospective, observational study designed to subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Bioresorbable vascular scaffolds, OCT, non-compliant ballooning
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 50 subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Consented subjects are to undergo PCI and have a lesion without angiographic calcification.
Who may be able to join
- Patients ≥18 years who undergo PCI of de novo lesions in the setting of stable angina or acute coronary syndromes.
- The culprit lesion must be successfully pre-dilated prior to enrollment. -
Who cannot join
- Patient specific
- Cardiogenic shock (sustained [>10 min] systolic blood pressure <90 mm Hg in absence of inotropic support or the presence of an intra-aortic balloon pump support).
- Known severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.72 m2).
- Intolerance of aspirin or thienopyridines
- ST-segment elevation myocardial infarction
- Subject is a woman of childbearing potential, pregnant, or nursing.
Show all 20Show fewer
- Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
- Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, ticagrelor or prasugrel, or to everolimus, PLLA polymers, or contrast sensitivity that cannot be adequately pre-medicated.
- Subject has a platelet count <100,000 cell/mm3 or >700,000 cell/mm3, a white blood cell count of <3,000 cell/mm3, or documented or suspected liver disease in the recent blood test.
- Lesion specific
- Left main disease defined as diameter stenosis >50%
- Ostial lesion
- Tortuous artery in which OCT is unable to pass
- Lesion in a bypass graft
- Reference vessel diameter (RVD) <2.5 mm or >4 mm
- Bifurcation lesions with side branches >2 mm
- In-stent restenosis
- Previous placement of a stent proximal or distal to or within 10 mm of the target lesion
- Chronic total occlusion
- Lesions with calcified plaque >180° by pre-intervention OCT
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St Francis Hospital
Roslyn, New York, 11576
Richard A Shlofmitz, MD, 516-390-9640, richard.shlofmitz@chsli.org
Elizabeth S Haag, RN MPA, 516 562-6790, elizabeth.haag@chsli.org
About this study
Official title: An Optical Coherence Tomography Evaluation of the Effects of High-Pressure, Non-compliant Ballooning on Scaffold Embedding
This study is a single-center, prospective, observational study designed to subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions.
Eligible subjects will have BVS scaffold implant using a high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. OCT ( optical coherence tomography ) will be used to evaluate the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.
Read the detailed description
This study is a single-center, prospective, observational study designed to enroll 50 subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Consented subjects are to undergo PCI and have a lesion without angiographic calcification.
Eligible subjects who meet inclusion and exclusion criteria for BVS scaffold implant will have a BVS-specific implantation protocol with high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. Because the scaffold is compliant, a perfectly embedded scaffold is sometimes observed in a lesion with soft plaque, resulting in a smaller intra-luminal scaffold volume that may reduce the event rate. Enrolled subjects will have OCT ( optical coherence tomography ) pre and post BVS implantation to assess the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation (using the moderate pressure of 12 atm) to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.
- Conditions
- Coronary Artery Disease
- Being tested
- Bioresorbable vascular scaffolds, OCT, non-compliant ballooning
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable vascular scaffolds, OCT, non-compliant ballooningDevice
Measure the effect of high-pressure, NC ballooning on scaffold embedding by OCT
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of the number of embedded scaffold struts as evaluated by OCT
Percentage of embedded scaffold strut is defined as the ratio of the number of embedded strut to the total number of analyzed strut per lesion. (% of embedded scaffold struts = No. of embedded struts / total No. of analyzed struts) The analysis will be done for both OCT images 1) after initial bioresorbable scaffold implantation using moderate pressure and 2) after post-dilatation using high pressure non-compliant balloon, and the change in percentage of embedded scaffold strut from initial bioresorbable scaffold implantation to post-dilation will be calculated. (∆ % of embedded scaffold struts = % of embedded scaffold struts of initial scaffold implantation - % of embedded scaffold struts of post-dilatation)
Measured: intra-procedure (PCI)
Secondary outcomes (6)
Change in minimum scaffold cross-sectional area
Minimum scaffold cross-sectional area defined as the smallest endoluminal area within the entire scaffold cross-section. We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon
Measured: intra-procedure (PCI)
Change in mean scaffold cross-sectional area
Mean scaffold cross-sectional area defined as the average of endoluminal area within the entire scaffold cross-section. We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon
Measured: intra-procedure (PCI)
Change in the ratio of minimum scaffold cross-sectional area and expected scaffold cross-sectional area from manufacturer chart of balloon
We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon.
Measured: intra-procedure (PCI)
Change in the ratio of minimum scaffold cross-sectional area and average of proximal and distal reference lumen cross-sectional
We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon
Measured: intra-procedure (PCI)
Change in the Percentage of footprint
Percentage of footprint defined as the ratio of outer BVS scaffold surface area to total luminal surface area. We will evaluate the change from initial bioresorbable scaffold implantation using moderate pressure to post-dilation using high pressure using non-compliant balloon
Measured: intra-procedure (PCI)
Comparison of scaffold embedding between non-calcified plaque and moderate calcified plaque (arc <180°)
In the strut level, the percentage of embedded scaffold struts between calcified plaque and non-calcified plaque will be compared. And about the lesion, Other secondary endpoints(2-7) listed above will be compared between calcified plaque and non-calcified plaque will be compared.
Measured: intra-procedure (PCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start30 Mar 2017
- Primary completion22 Mar 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Francis Hospital, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Akiko Maehara, MD
- Responsible party
- Principal investigator, Richard A. Shlofmitz, MD, St. Francis Hospital, New York
- Investigators
- Richard A Shlofmitz, MD, Principal investigator, St FrancisHospiral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106961
- Sponsor's protocol ID
- 16-19
- Status last verified
- Oct 2016
- First submitted
- 4 Oct 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Munzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015 Feb;10(10):1144-53. doi: 10.4244/EIJY14M07_11.
PubMed 25042421Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, Scalone G, Schulz E, Chan MY, Kocka V, Hurtado J, Gomez-Hospital JA, Munzel T, Lee CH, Cequier A, Valdes M, Widimsky P, Serruys PW, Sabate M. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):189-197. doi: 10.1016/j.jcin.2014.10.005.
PubMed 25616924Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
PubMed 26825231Cassese S, Byrne RA, Ndrepepa G, Kufner S, Wiebe J, Repp J, Schunkert H, Fusaro M, Kimura T, Kastrati A. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet. 2016 Feb 6;387(10018):537-544. doi: 10.1016/S0140-6736(15)00979-4. Epub 2015 Nov 17.
PubMed 26597771Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, Binder H, Eggebrecht H, Munzel T, Cook S, Gori T. Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol. 2016 Mar 1;67(8):921-931. doi: 10.1016/j.jacc.2015.12.019.
PubMed 26916481
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optical Coherence Tomography Evaluation of the Effects of High-Pressure, Non-compliant Ballooning on Scaffold Embedding
- ClinicalTrials.gov ID
- NCT03106961
- Acronym / sponsor ID
- 16-19
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Francis Hospital, New YorkUniversity, hospital or other
- Collaborators
- Akiko Maehara, MD
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 22 Mar 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 11 Apr 2017 (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.
This study is a single-center, prospective, observational study designed to subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions.
Eligible subjects will have BVS scaffold implant using a high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. OCT ( optical coherence tomography ) will be used to evaluate the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.
Detailed description
This study is a single-center, prospective, observational study designed to enroll 50 subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Consented subjects are to undergo PCI and have a lesion without angiographic calcification.
Eligible subjects who meet inclusion and exclusion criteria for BVS scaffold implant will have a BVS-specific implantation protocol with high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. Because the scaffold is compliant, a perfectly embedded scaffold is sometimes observed in a lesion with soft plaque, resulting in a smaller intra-luminal scaffold volume that may reduce the event rate. Enrolled subjects will have OCT ( optical coherence tomography ) pre and post BVS implantation to assess the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation (using the moderate pressure of 12 atm) to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 50 subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Consented subjects are to undergo PCI and have a lesion without angiographic calcification.
Key inclusion criteria (2 listed)
- Patients ≥18 years who undergo PCI of de novo lesions in the setting of stable angina or acute coronary syndromes.
- The culprit lesion must be successfully pre-dilated prior to enrollment. -
Key exclusion criteria (20 listed)
- Patient specific
- Cardiogenic shock (sustained [>10 min] systolic blood pressure <90 mm Hg in absence of inotropic support or the presence of an intra-aortic balloon pump support).
- Known severe renal insufficiency (estimated glomerular filtration rate <30 mL/min/1.72 m2).
- Intolerance of aspirin or thienopyridines
- ST-segment elevation myocardial infarction
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 |
|---|---|---|
| Bioresorbable vascular scaffolds, OCT, non-compliant ballooningMeasure the effect of high-pressure, NC ballooning on scaffold embedding by OCT | Device | – |
Primary outcome
Change in the percentage of the number of embedded scaffold struts as evaluated by OCT
Time frame: intra-procedure (PCI)
Percentage of embedded scaffold strut is defined as the ratio of the number of embedded strut to the total number of analyzed strut per lesion. (% of embedded scaffold struts = No. of embedded struts / total No. of analyzed struts) The analysis will be done for both OCT images 1) after initial bioresorbable scaffold implantation using moderate pressure and 2) after post-dilatation using high pressure non-compliant balloon, and the change in percentage of embedded scaffold strut from initial bioresorbable scaffold implantation to post-dilation will be calculated. (∆ % of embedded scaffold struts = % of embedded scaffold struts of initial scaffold implantation - % of embedded scaffold struts of post-dilatation)
6 secondary outcomes
Change in minimum scaffold cross-sectional area
Time frame: intra-procedure (PCI)
Change in mean scaffold cross-sectional area
Time frame: intra-procedure (PCI)
Change in the ratio of minimum scaffold cross-sectional area and expected scaffold cross-sectional area from manufacturer chart of balloon
Time frame: intra-procedure (PCI)
Change in the ratio of minimum scaffold cross-sectional area and average of proximal and distal reference lumen cross-sectional
Time frame: intra-procedure (PCI)
Change in the Percentage of footprint
Time frame: intra-procedure (PCI)
Comparison of scaffold embedding between non-calcified plaque and moderate calcified plaque (arc <180°)
Time frame: intra-procedure (PCI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Background: PubMed 25042421Capodanno D, Gori T, Nef H, Latib A, Mehilli J, Lesiak M, Caramanno G, Naber C, Di Mario C, Colombo A, Capranzano P, Wiebe J, Araszkiewicz A, Geraci S, Pyxaras S, Mattesini A, Naganuma T, Munzel T, Tamburino C. Percutaneous coronary intervention with everolimus-eluting bioresorbable vascular scaffolds in routine clinical practice: early and midterm outcomes from the European multicentre GHOST-EU registry. EuroIntervention. 2015 Feb;10(10):1144-53. doi: 10.4244/EIJY14M07_11.
- Background: PubMed 25616924Brugaletta S, Gori T, Low AF, Tousek P, Pinar E, Gomez-Lara J, Scalone G, Schulz E, Chan MY, Kocka V, Hurtado J, Gomez-Hospital JA, Munzel T, Lee CH, Cequier A, Valdes M, Widimsky P, Serruys PW, Sabate M. Absorb bioresorbable vascular scaffold versus everolimus-eluting metallic stent in ST-segment elevation myocardial infarction: 1-year results of a propensity score matching comparison: the BVS-EXAMINATION Study (bioresorbable vascular scaffold-a clinical evaluation of everolimus eluting coronary stents in the treatment of patients with ST-segment elevation myocardial infarction). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt B):189-197. doi: 10.1016/j.jcin.2014.10.005.
- Background: PubMed 26825231Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
- Background: PubMed 26597771Cassese S, Byrne RA, Ndrepepa G, Kufner S, Wiebe J, Repp J, Schunkert H, Fusaro M, Kimura T, Kastrati A. Everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials. Lancet. 2016 Feb 6;387(10018):537-544. doi: 10.1016/S0140-6736(15)00979-4. Epub 2015 Nov 17.
- Background: PubMed 26916481Puricel S, Cuculi F, Weissner M, Schmermund A, Jamshidi P, Nyffenegger T, Binder H, Eggebrecht H, Munzel T, Cook S, Gori T. Bioresorbable Coronary Scaffold Thrombosis: Multicenter Comprehensive Analysis of Clinical Presentation, Mechanisms, and Predictors. J Am Coll Cardiol. 2016 Mar 1;67(8):921-931. doi: 10.1016/j.jacc.2015.12.019.
- Individual participant dataSharing planned: Undecided
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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.
Richard A Shlofmitz, MD principal investigator
St FrancisHospiral
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by St. Francis Hospital, New York at 1 site 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 2 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricahrd A Shlofmitz, MD (516 390-9640, richard.shlofmitz@chsli.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the percentage of the number of embedded scaffold struts as evaluated by OCT (time frame: intra-procedure (PCI)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03106961, which also lists 5 linked publications.
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 Apr 2017.