Coronary Artery DiseasePhase 2/3DISCOVERNCT00264043
The Study to Evaluate Patient Outcome Using Distal Protection Combined With the BX Velocity.
A Phase 2/3 study testing emboli capturing guidewire device combined with stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Germany.
Trial summary
The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month. 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?
- emboli capturing guidewire device combined with stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2000to Jun 2002
- Phase
- Phase 2/3
- 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
- Unstable angina pectoris (Braunwald classification B \& C, I-II-III, native vessels)
- or lesion located in the SVG;
- Single de novo or restenotic lesion requiring treatment in a major native coronary artery or saphenous vein graft;
- The vessel diameter to place the AngioGuard™ device in must be > 3 and < 5.5 mm (6.5 when the 7mm AngioGuard™ is available);
- Target lesion stenosis is >50% and <100% (TIMI 1).
Who cannot join
- A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
- More than one coronary artery is 100% occluded;
- Patient has unprotected left main coronary disease with > 50% stenosis;
- Patient has an ostial target lesion;
- Significant (>50%) untreated stenosis proximal or distal to the target lesion that will be treated during the procedure, since this may require revascularization or impede runoff;
- Ejection fraction <30%;
- Totally occluded vessel (TIMI 0 Level).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.
The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.
Read the detailed description
This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuard™ device and Bx Velocity™ stent and will be followed for six-months post-procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- emboli capturing guidewire device combined with stent
- 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.
emboli capturing guidewire device combined with stentDevice
Also called emboli capturing guidewire device, PTCA
AngioGuard™ device and Bx Velocity™ stent
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AngioGuard™ device and Bx Velocity™ stent Receives: Device: emboli capturing guidewire device combined with stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent
Measured: 1 month
Secondary outcomes (3)
successful placement and retrieval without embolic occlusions of vessels distal to the position of the device
Measured: post-procedure
overall survival rates
Measured: 1 month and 6 months
device evaluation
Measured: post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startMay 2000
- Primary completionFeb 2002
- Study completionJun 2002
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eberhard Grube, MD, Principal investigator, Herzzentrum Siegburg GMBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264043
- Sponsor's protocol ID
- EC99-09
- Acronym
- DISCOVER
- Status last verified
- Aug 2008
- First submitted
- 9 Dec 2005
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Protection Combined With Velocity in Coronary Arteries and SVBG Registry.
- ClinicalTrials.gov ID
- NCT00264043
- Acronym / sponsor ID
- DISCOVER / EC99-09
- Conditions
- Coronary Artery Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Feb 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 12 Dec 2005 (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.
The primary objective is to evaluate the use of the AngioGuard™ device combined with the Bx Velocity™ on patient outcome at one month.
Detailed description
This is a prospective, non-randomized, multi-center trial. Patients will be treated with the AngioGuard™ device and Bx Velocity™ stent and will be followed for six-months post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: emboli capturing guidewire device combined with stentAngioGuard™ device and Bx Velocity™ stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unstable angina pectoris (Braunwald classification B \& C, I-II-III, native vessels)
- or lesion located in the SVG;
- Single de novo or restenotic lesion requiring treatment in a major native coronary artery or saphenous vein graft;
- The vessel diameter to place the AngioGuard™ device in must be > 3 and < 5.5 mm (6.5 when the 7mm AngioGuard™ is available);
- Target lesion stenosis is >50% and <100% (TIMI 1).
Key exclusion criteria (7 listed)
- A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
- More than one coronary artery is 100% occluded;
- Patient has unprotected left main coronary disease with > 50% stenosis;
- Patient has an ostial target lesion;
- Significant (>50%) untreated stenosis proximal or distal to the target lesion that will be treated during the procedure, since this may require revascularization or impede runoff;
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 |
|---|---|---|
| emboli capturing guidewire device combined with stentAlso: emboli capturing guidewire device, PTCAAngioGuard™ device and Bx Velocity™ stent | Device | 1 |
Primary outcome
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent
Time frame: 1 month
3 secondary outcomes
successful placement and retrieval without embolic occlusions of vessels distal to the position of the device
Time frame: post-procedure
overall survival rates
Time frame: 1 month and 6 months
device evaluation
Time frame: post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Eberhard Grube, MD principal investigator
Herzzentrum Siegburg GMBH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing emboli capturing guidewire device combined with stent in people with Coronary Artery Disease, run by Cordis US Corp. at 1 site in Germany.
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 7 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 6 Aug 2008. 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 Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical success of the AngioGuard™ device combined with the Bx Velocity™ stent (time frame: 1 month). 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 6 Aug 2008.