Coronary Artery Disease, Autosomal Dominant, 1Phase 4PROTECT-CANCT00846846
PROTECT Continued Access Post Marketing Surveillance Trial
A Phase 4 study testing Endeavor® Zotarolimus Eluting Coronary Stent System in people with Coronary Artery Disease, Autosomal Dominant, 1, run by Medtronic Vascular at 1 site in United States.
Trial summary
In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is "PROTECT CONTINUED ACCESS" ("PROTECT CA"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Autosomal Dominant, 1
- What is being tested?
- Endeavor® Zotarolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,018 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2015
- Phase
- Phase 4
- 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
Who may be able to join
- Patient is > 18 years of age (or minimum age as required by local regulations).
- The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".
- All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System.
- Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System. Please check the 'Instructions for Use' that comes with the product. Please be aware that the 'Instructions for Use' may be subject to change during the course of the study.
- 5 The patient is willing and able to cooperate with study procedures and required follow up visits.
Who cannot join
- Women with known pregnancy or who are lactating.
- Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.
- Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.
- Previous brachytherapy.
- Previous implantation of a drug eluting stent.
- Previous implantation of a bare metal stent in the preceding year.
Show all 16Show fewer
- Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.
- Current medical condition with a life expectancy of less than 3 years.
- Manifest acute severe heart failure (Killip class III-IV).
- The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once.
- Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
- Patients on warfarin or similar anti-coagulant therapy.
- Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use.
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
- Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
- 16 Transplant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01605
About this study
Official title: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial: PROTECT Continued Access Post Marketing Surveillance Trial
In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is "PROTECT CONTINUED ACCESS" ("PROTECT CA").
Read the detailed description
This was a prospective, multicenter, non-randomized, single-arm, open-label post market surveillance study designed to expand safety information in patients treated with the Endeavor® Zotarolimus Eluting Coronary Stent System.
Since their introduction, Drug Eluting Stents (DES) have markedly decreased stent restenosis and the clinical need for repeat revascularization frequently observed with bare metal stents (BMS)1-10. However, the widespread use of DES has raised concerns regarding the occurrence of late stent thrombosis (> 30 days after stent implantation)12-14. Although the incidence might seem low (0.2-0.7%)13,15-18 the high mortality and morbidity associated with stent thrombosis, and the soaring number of stents implanted annually, make it a significant medical problem.
The purpose of this trial was to investigate the long-term clinical safety and efficacy of the Endeavor drug eluting stent in a large and higher risk patient population, which more closely reflects clinical practice today. Both unstable and stable patients with single or multivessel disease and complex lesions were eligible for enrollment.
The selected primary endpoint was stent thrombosis, defined as definite and probable stent thrombosis according to the ARC definition, at 3 years. The main secondary endpoints were the composite of death or cardiac death combined with large or all non-fatal myocardial infarction, which are the typical clinical manifestations of stent thrombosis. These events are adjudicated by a clinical events committee.
1.2 Study Endpoints 1.2.1 Primary Endpoint: The overall stent thrombosis rate defined as definite and probable stent thrombosis according to the ARC definition at 3 years 1.2.2 Secondary Endpoints:
Main Secondary Endpoints include:
- Composite endpoint of total death and number of patients with all non-fatal myocardial infarction at 3 years
- Composite endpoint of cardiac death and number of patients with all non-fatal myocardial infarction at 3 years
- Composite endpoint of total death and number of patients with large non-fatal myocardial infarction at 3 years
- Composite endpoint of cardiac death and number of patients with large non-fatal myocardial infarction at 3 years
Additional secondary endpoints include:
- Total Death and subcategories of Death
- Large and all Myocardial Infarction (MI)
- Stent thrombosis defined as definite, probable and possible
- Composite score of clinical outcomes (death, myocardial infarction, stroke and revascularization) *
- Major Adverse Cardiac and Cerebral Events (MACCE)
- Stroke (hemorrhagic in nature while on clopidogrel)
- Bleeding complications in general
- Target lesion revascularization (TLR)
- Target vessel revascularization (TVR)
- Non target vessel revascularization (non TVR)
- Procedural success
- Device success
- Lesion success
- Endpoints will be calculated at the follow-up time points and for the mean follow-up period.
- The composite score of clinical outcomes (death, myocardial infarction, stroke and revascularization) constructed from a patient population according to the Delphi method.
- Being tested
- Endeavor® Zotarolimus Eluting Coronary Stent System
- Medical subject headings
- Coronary Artery Disease, Autosomal Dominant, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endeavor® Zotarolimus Eluting Coronary Stent SystemDevice
Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation
| Study group | Role | What they receive |
|---|---|---|
| Endeavor® Zotarolimus Eluting Coronary Stent | Experimental | Endeavor® Zotarolimus Eluting Coronary Stent System Receives: Device: Endeavor® Zotarolimus Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation
The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.
Measured: 3 years
Secondary outcomes (1)
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.
Total death and and number of patients with all non-fatal myocardial infarction. Cardiac death and number of patients with all non-fatal myocardial infarction. Total death and number of patients with large non-fatal myocardial infarction. Cardiac death and number of patients with large non-fatal myocardial infarction.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2013
- Study completionMar 2015
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 Disease, Autosomal Dominant, 1Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Bousquette, Study director, Medtronic Cardiovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846846
- Sponsor's protocol ID
- Version 1.0, 29 October 2008
- Acronym
- PROTECT-CA
- Status last verified
- Apr 2015
- First submitted
- 18 Feb 2009
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial: PROTECT Continued Access Post Marketing Surveillance Trial
- ClinicalTrials.gov ID
- NCT00846846
- Acronym / sponsor ID
- PROTECT-CA / Version 1.0, 29 October 2008
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,018 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 2 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to expand safety information in patients treated with the Endeavor Drug Eluting Stent System, or next generation model, a Continued Access (CA) study is added to the PROTECT Trial. The amended study is "PROTECT CONTINUED ACCESS" ("PROTECT CA").
Detailed description
This was a prospective, multicenter, non-randomized, single-arm, open-label post market surveillance study designed to expand safety information in patients treated with the Endeavor® Zotarolimus Eluting Coronary Stent System.
Since their introduction, Drug Eluting Stents (DES) have markedly decreased stent restenosis and the clinical need for repeat revascularization frequently observed with bare metal stents (BMS)1-10. However, the widespread use of DES has raised concerns regarding the occurrence of late stent thrombosis (> 30 days after stent implantation)12-14. Although the incidence might seem low (0.2-0.7%)13,15-18 the high mortality and morbidity associated with stent thrombosis, and the soaring number of stents implanted annually, make it a significant medical problem.
The purpose of this trial was to investigate the long-term clinical safety and efficacy of the Endeavor drug eluting stent in a large and higher risk patient population, which more closely reflects clinical practice today. Both unstable and stable patients with single or multivessel disease and complex lesions were eligible for enrollment.
The selected primary endpoint was stent thrombosis, defined as definite and probable stent thrombosis according to the ARC definition, at 3 years. The main secondary endpoints were the composite of death or cardiac death combined with large or all non-fatal myocardial infarction, which are the typical clinical manifestations of stent thrombosis. These events are adjudicated by a clinical events committee.
1.2 Study Endpoints 1.2.1 Primary Endpoint: The overall stent thrombosis rate defined as definite and probable stent thrombosis according to the ARC definition at 3 years 1.2.2 Secondary Endpoints:
Main Secondary Endpoints include:
- Composite endpoint of total death and number of patients with all non-fatal myocardial infarction at 3 years
- Composite endpoint of cardiac death and number of patients with all non-fatal myocardial infarction at 3 years
- Composite endpoint of total death and number of patients with large non-fatal myocardial infarction at 3 years
- Composite endpoint of cardiac death and number of patients with large non-fatal myocardial infarction at 3 years
Additional secondary endpoints include:
- Total Death and subcategories of Death
- Large and all Myocardial Infarction (MI)
- Stent thrombosis defined as definite, probable and possible
- Composite score of clinical outcomes (death, myocardial infarction, stroke and revascularization) *
- Major Adverse Cardiac and Cerebral Events (MACCE)
- Stroke (hemorrhagic in nature while on clopidogrel)
- Bleeding complications in general
- Target lesion revascularization (TLR)
- Target vessel revascularization (TVR)
- Non target vessel revascularization (non TVR)
- Procedural success
- Device success
- Lesion success
- Endpoints will be calculated at the follow-up time points and for the mean follow-up period.
- The composite score of clinical outcomes (death, myocardial infarction, stroke and revascularization) constructed from a patient population according to the Delphi method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endeavor® Zotarolimus Eluting Coronary Stent | Experimental | Device: Endeavor® Zotarolimus Eluting Coronary Stent SystemEndeavor® Zotarolimus Eluting Coronary Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is > 18 years of age (or minimum age as required by local regulations).
- The patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".
- All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System.
- Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System. Please check the 'Instructions for Use' that comes with the product. Please be aware that the 'Instructions for Use' may be subject to change during the course of the study.
- 5 The patient is willing and able to cooperate with study procedures and required follow up visits.
Key exclusion criteria (16 listed)
- Women with known pregnancy or who are lactating.
- Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.
- Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.
- Previous brachytherapy.
- Previous implantation of a drug eluting stent.
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 |
|---|---|---|
| Endeavor® Zotarolimus Eluting Coronary Stent SystemEndeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation | Device | Endeavor® Zotarolimus Eluting Coronary Stent |
Primary outcome
To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation
Time frame: 3 years
The primary endpoint rate of ARC-defined definite or probable stent thrombosis at 3 years.
1 secondary outcome
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions.
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lisa Bousquette study director
Medtronic Cardiovascular
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endeavor® Zotarolimus Eluting Coronary Stent System in people with Coronary Artery Disease, Autosomal Dominant, 1, run by Medtronic Vascular 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 4 May 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2014). 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?
To Evaluate Overall Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System in a Patient Population Requiring Stent Implantation (time frame: 3 years). 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 4 May 2015.