Coronary Artery DiseaseNCT00801710
CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
A study testing BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) in people with Coronary Artery Disease and Coronary Artery Chronic Total Occlusion, run by Boston Scientific Corporation at 4 sites in Germany.
Trial summary
This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (CTO). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Chronic Total Occlusion
- What is being tested?
- BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesGermany
- Study dates
- Sep 2008to Sep 2009
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suitable for coronary intervention
- de novo or restenotic CTO at least 3 months old, in proximal or mid coronary artery segment, 3.0-5.0 mm in diameter
- Mild/moderate proximal vessel tortuosity
- Mild/moderate lesion angulation
- Mild/moderate calcification
- Satisfactory distal vessel visualization
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- Mild/moderate side branch interference
- 19 years old
- BMI<40
- LVEF>20%
- Signed informed consent
Who cannot join
- Extensive dissection from guidewire manipulation
- SVG or in-stent CTO
- Aorto-ostial CTO
- Unable to take aspirin, Clopidogrel, or Ticlopidine
- Thrombus/vessel filling defects
- Severe cerebrovascular disease/stroke within 1 month
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- Intervention within 2 weeks
- Renal insufficiency
- GI bleeding
- Active infection
- Life expectancy <2 years
- Significant anemia
- Uncontrolled hypertension
- Severe electrolyte imbalance
- Anaphylaxis to contrast
- NYHA class IV
- Unstable angina requiring intervention
- MI within 2 weeks
- Uncontrolled diabetes
- Participating in another protocol
- Unwilling/unable to comply with protocol
- Angina/ischemia caused by target vessel
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Main Taunus Hospital
Bad Soden
Klinikum Darmstadt
Darmstadt
CardioVascular Center Frankfurt, St. Katharinen Hospital
Frankfurt
Universitäres Herz- und Gefässzentrum Hamburg
Hamburg
About this study
This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (CTO).
The hypothesis is that the BridgePoint Medical System can do this without an increase in major complications.
- Being tested
- BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)
- 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.
BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)Device
Revascularization of coronary artery chronic total occlusion.
Use of the BridgePoint Medical System to cross coronary CTOs prior to definitive revascularization treatment via angioplasty and/or stent implant
| Study group | Role | What they receive |
|---|---|---|
| BridgePoint Medial System | Experimental | Not described Receives: Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTO Crossing Rate
Measured: Peri-procedural
Secondary outcomes (3)
Major Adverse Cardiac Events (MACE)
Measured: 30 days
Perforation rate
Measured: Peri-procedural
Acute myocardial infarction (AMI)
Measured: Peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2009
- Study completionSep 2009
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.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BridgePoint Medical
- Responsible party
- Sponsor
- Investigators
- Horst Sievert, MD, Principal investigator, CardioVascular Center Frankfurt, St. Katharinen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801710
- Sponsor's protocol ID
- 200-0001
- Status last verified
- Jan 2021
- First submitted
- 2 Dec 2008
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CrossBoss and Stingray Catheter and Entera Guidewire Chronic Total Occlusion (CTO) Study
- ClinicalTrials.gov ID
- NCT00801710
- Acronym / sponsor ID
- 200-0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- BridgePoint Medical
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 3 Dec 2008 (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.
This study is to determine if the BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) can facilitate safe and effective placement of a guidewire in the true lumen of coronary vessels distal to a chronic total occlusion (CTO).
The hypothesis is that the BridgePoint Medical System can do this without an increase in major complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BridgePoint Medial System | Experimental | Device: BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Suitable for coronary intervention
- de novo or restenotic CTO at least 3 months old, in proximal or mid coronary artery segment, 3.0-5.0 mm in diameter
- Mild/moderate proximal vessel tortuosity
- Mild/moderate lesion angulation
- Mild/moderate calcification
Key exclusion criteria (22 listed)
- Extensive dissection from guidewire manipulation
- SVG or in-stent CTO
- Aorto-ostial CTO
- Unable to take aspirin, Clopidogrel, or Ticlopidine
- Thrombus/vessel filling defects
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 |
|---|---|---|
| BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire)Revascularization of coronary artery chronic total occlusion. Use of the BridgePoint Medical System to cross coronary CTOs prior to definitive revascularization treatment via angioplasty and/or stent implant | Device | BridgePoint Medial System |
Primary outcome
CTO Crossing Rate
Time frame: Peri-procedural
3 secondary outcomes
Major Adverse Cardiac Events (MACE)
Time frame: 30 days
Perforation rate
Time frame: Peri-procedural
Acute myocardial infarction (AMI)
Time frame: Peri-procedural
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 26 Jan 2021.
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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.
Horst Sievert, MD principal investigator
CardioVascular Center Frankfurt, St. Katharinen Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BridgePoint Medical System (CrossBoss Catheter, Stingray Catheter, Entera Guidewire) in people with Coronary Artery Disease and Coronary Artery Chronic Total Occlusion, run by Boston Scientific Corporation at 4 sites 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 11 inclusion and 22 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 26 Jan 2021. 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 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.
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?
CTO Crossing Rate (time frame: Peri-procedural). 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 26 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.