Aortic Valve StenosisNCT01514994
Valvuloplasty Scoring Balloon Catheter First-in-Man Study
A study testing AngioScore's Valvuloplasty Scoring Balloon in people with Aortic Valve Stenosis, run by Spectranetics Corporation at 1 site in Canada.
Trial summary
The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- AngioScore's Valvuloplasty Scoring Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Sep 2015
- 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
- Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of >40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area < 0.8 cm2.
- Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater
- Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.
- Phase 1 patients must be scheduled for a surgical aortic valve replacement.
- Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.
Who cannot join
- Recent myocardial infarction (<30days)
- Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis
- Any sepsis, including active endocarditis
- Concomitant 2+ or greater aortic valve valve regurgitation
- LVEF < 20%
- CVA or TIA within the previous 6 months
- Previous aortic valve replacement (bioprosthetic or mechanical)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study
The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.
Read the detailed description
Phase 1 will enroll patient who are scheduled to undergo open surgical aortic valve replacement and will have the Valvuloplasty Scoring Balloon delivered to their stenotic aortic valve through a standard aortotomy and deployed immediately prior to valve replacement.
Phase 2 will enroll patients with aortic valve stenosis who are deemed to not be suitable candidates for elective surgical aortic valve replacement and in whom the investigational Valvuloplasty Scoring Balloon will be used as a stand-alone Valvuloplasty procedure or "bridge" to trans-catheter aortic valve implantation (TAVI) or surgery.
- Conditions
- Aortic Valve Stenosis
- Being tested
- AngioScore's Valvuloplasty Scoring Balloon
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioScore's Valvuloplasty Scoring BalloonDevice
All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.
| Study group | Role | What they receive |
|---|---|---|
| AngioScore's Valvuloplasty Scoring Balloon | Experimental | Not described Receives: Device: AngioScore's Valvuloplasty Scoring Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Procedural success defined as a >50% increase in the aortic valve effective orifice area and less than or equal to 2+ valvular regurgitation at the end of the percutaneous valvuloplasty procedure utilizing echocardiography, hemodynamic measurements and angiography.
Measured: 1 day
Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization.
Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery
Measured: Participants will be followed for the duration of the hospital stay, an expected average of 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John G. Webb, MD, Principal investigator, St. Paul's Hospital, Vancouver, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514994
- Sponsor's protocol ID
- ST-1486
- Status last verified
- Apr 2016
- First submitted
- 11 Jan 2012
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Critical Aortic Valve Stenosis Using a Novel Valvuloplasty Scoring Balloon Catheter: a First-in-Man Study
- ClinicalTrials.gov ID
- NCT01514994
- Acronym / sponsor ID
- ST-1486
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Jan 2012 (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 Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.
Detailed description
Phase 1 will enroll patient who are scheduled to undergo open surgical aortic valve replacement and will have the Valvuloplasty Scoring Balloon delivered to their stenotic aortic valve through a standard aortotomy and deployed immediately prior to valve replacement.
Phase 2 will enroll patients with aortic valve stenosis who are deemed to not be suitable candidates for elective surgical aortic valve replacement and in whom the investigational Valvuloplasty Scoring Balloon will be used as a stand-alone Valvuloplasty procedure or "bridge" to trans-catheter aortic valve implantation (TAVI) or surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AngioScore's Valvuloplasty Scoring Balloon | Experimental | Device: AngioScore's Valvuloplasty Scoring Balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of >40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area < 0.8 cm2.
- Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater
- Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.
- Phase 1 patients must be scheduled for a surgical aortic valve replacement.
- Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.
Key exclusion criteria (7 listed)
- Recent myocardial infarction (<30days)
- Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis
- Any sepsis, including active endocarditis
- Concomitant 2+ or greater aortic valve valve regurgitation
- LVEF < 20%
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 |
|---|---|---|
| AngioScore's Valvuloplasty Scoring BalloonAll patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter. | Device | AngioScore's Valvuloplasty Scoring Balloon |
Primary outcome
Procedural Success
Time frame: 1 day
Procedural success defined as a >50% increase in the aortic valve effective orifice area and less than or equal to 2+ valvular regurgitation at the end of the percutaneous valvuloplasty procedure utilizing echocardiography, hemodynamic measurements and angiography.
Number of participants who do not experience death, stroke, myocardial infarction or emergency cardiac surgery during their hospitalization.
Time frame: Participants will be followed for the duration of the hospital stay, an expected average of 48 hours
Freedom from in-hospital death, stroke, myocardial infarction or emergency cardiac surgery
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 18 Apr 2016.
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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.
John G. Webb, MD principal investigator
St. Paul's Hospital, Vancouver, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AngioScore's Valvuloplasty Scoring Balloon in people with Aortic Valve Stenosis, run by Spectranetics Corporation at 1 site in Canada.
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 18 Apr 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 Canada. 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?
Procedural Success (time frame: 1 day). The study lists 2 primary outcomes in all. 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 Apr 2016.