Coronary Artery DiseaseDISCRETE-CTONCT02936011
DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in CTO.
A study testing CTO PCI using Absorb Bioresorbable Vascular Scaffolds in people with Coronary Artery Disease, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular Scaffold (BVS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CTO PCI using Absorb Bioresorbable Vascular Scaffolds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2016to Mar 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient >18 years old with capacity to provide informed consent
- Females of childbearing potential have a negative pregnancy test
- Subject understands the trial requirements, the treatment procedures and provides written informed consent
- Presence of Chronic Total Occlusion (CTO) in a main epicardial coronary vessel that is known or presumed to be of at least 3 months in duration
- The CTO has been crossed using ADR or RDR techniques and subintimal wire passage is documented on IVUS
- Target vessel is >2.5mm and <4mm in diameter and the lesion can the diseased segment can be covered with 3 Absorb BVS stents
- Target lesion is fully prepared and dilatable before BVS insertion • Absorb BVS are successfully implanted in the target lesion
Who cannot join
- Acute myocardial infarction with ongoing ST-elevation
- Cardiogenic shock
- Left ventricular ejection fraction <20%
- Subject has one of the following (as assessed prior to the index procedure): - Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months; Current problems with substance abuse; There is a planned non-cardiac procedure that may cause non-compliance with the protocol or confound data interpretation
- Subject will has a condition meaning they are unlikely to tolerate dual antiplatelet therapy for 12 months Subject is treated by dialysis or has a baseline serum creatinine level >220 μmol/L (2.5 mg/dL)
- Known allergy to to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g. Everolimus or PLLA polymer, all P2Y12 inhibitors, or aspirin)
Show all 13Show fewer
- Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint OR subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
- Need for ongoing long-term anticoagulation
- Subject has received an organ transplant or is on a waiting list for an organ transplant •Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
- Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
- Presence of a stent occlusion or the subject was previously treated at any time with intravascular brachytherapy
- Subject has a clinically significant bleeding diathesis or coagulopathy or will refuse blood transfusions
- Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Belfast Health & Social Care Trust
Belfast, BT12 6BA
Alison Murphy, 00442890636349, alison.murphy@belfasttrust.hscni.net
About this study
Official title: DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in Chronic Total Occlusion. The DISCRETE CTO Study.
Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular Scaffold (BVS).
Read the detailed description
This is a pilot study, with the aim of hypothesis generation. This research aims to establish the feasibility and safety of treating chronic total occlusions using dissection and re-entry techniques in combination with everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS).
Primary aims of the study are:
- To demonstrate a low rate of Target Vessel Failure (stent thrombosis, restenosis or late closure) at 12 and 24 months after CTO PCI and stenting with the Absorb BVS
- To demonstrate a high degree of endothelial stent strut coverage at 12 and 24 moths after CTO PCI and stenting with the Absorb BVSThe primary outcome measure is
- Conditions
- Coronary Artery Disease
- Being tested
- CTO PCI using Absorb Bioresorbable Vascular Scaffolds
- 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.
CTO PCI using Absorb Bioresorbable Vascular ScaffoldsDevice
CTO PCI
| Study group | Role | What they receive |
|---|---|---|
| CTO PCI with Absorb BVS | Other | Single arm observational after successful CTO PCI with Absorb BVS after antegrade or retrograde dissection and re-entry Receives: Device: CTO PCI using Absorb Bioresorbable Vascular Scaffolds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure as per ARC criteria (composite occurrence of any revascularization of the target lesion, myocardial infarction (MI) related to the target vessel, or cardiac death)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol Royal Infirmary, Golden Jubilee National Hospital, Royal Infirmary of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Simon J Walsh, MD, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936011
- Sponsor's protocol ID
- 15094SW-AS
- Acronym
- DISCRETE-CTO
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DISsection RE-entry Evaluation With Absorb Bioresorbable Vascular Scaffolds in Chronic Total Occlusion. The DISCRETE CTO Study.
- ClinicalTrials.gov ID
- NCT02936011
- Acronym / sponsor ID
- DISCRETE-CTO / 15094SW-AS
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Bristol Royal Infirmary, Golden Jubilee National Hospital, Royal Infirmary of Edinburgh
- Study start
- Oct 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- 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.
Percutaneous Coronary Intervention (PCI) is increasingly effective to treat Chronic Total Occlusion (CTO) lesions in coronary arteries. This trial will examine modern dissection and re-entry approaches to treat more complex CTO lesions with the Absorb Bioresorbable Vascular Scaffold (BVS).
Detailed description
This is a pilot study, with the aim of hypothesis generation. This research aims to establish the feasibility and safety of treating chronic total occlusions using dissection and re-entry techniques in combination with everolimus-eluting bioresorbable vascular scaffolds (Absorb BVS).
Primary aims of the study are:
- To demonstrate a low rate of Target Vessel Failure (stent thrombosis, restenosis or late closure) at 12 and 24 months after CTO PCI and stenting with the Absorb BVS
- To demonstrate a high degree of endothelial stent strut coverage at 12 and 24 moths after CTO PCI and stenting with the Absorb BVSThe primary outcome measure is
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTO PCI with Absorb BVS | Other | Device: CTO PCI using Absorb Bioresorbable Vascular ScaffoldsSingle arm observational after successful CTO PCI with Absorb BVS after antegrade or retrograde dissection and re-entry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patient >18 years old with capacity to provide informed consent
- Females of childbearing potential have a negative pregnancy test
- Subject understands the trial requirements, the treatment procedures and provides written informed consent
- Presence of Chronic Total Occlusion (CTO) in a main epicardial coronary vessel that is known or presumed to be of at least 3 months in duration
- The CTO has been crossed using ADR or RDR techniques and subintimal wire passage is documented on IVUS
Key exclusion criteria (13 listed)
- Acute myocardial infarction with ongoing ST-elevation
- Cardiogenic shock
- Left ventricular ejection fraction <20%
- Subject has one of the following (as assessed prior to the index procedure): - Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months; Current problems with substance abuse; There is a planned non-cardiac procedure that may cause non-compliance with the protocol or confound data interpretation
- Subject will has a condition meaning they are unlikely to tolerate dual antiplatelet therapy for 12 months Subject is treated by dialysis or has a baseline serum creatinine level >220 μmol/L (2.5 mg/dL)
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 |
|---|---|---|
| CTO PCI using Absorb Bioresorbable Vascular ScaffoldsCTO PCI | Device | CTO PCI with Absorb BVS |
Primary outcome
Target Vessel Failure as per ARC criteria (composite occurrence of any revascularization of the target lesion, myocardial infarction (MI) related to the target vessel, or cardiac death)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
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
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.
Simon J Walsh, MD principal investigator
Belfast Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTO PCI using Absorb Bioresorbable Vascular Scaffolds in people with Coronary Artery Disease, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 7 inclusion and 13 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 18 Oct 2016. 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 Kingdom. 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 Alison Murphy (00442890636349, alison.murphy@belfasttrust.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure as per ARC criteria (composite occurrence of any revascularization of the target lesion, myocardial infarction (MI) related to the target vessel, or cardiac death) (time frame: 12 months). 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 18 Oct 2016.