Peripheral Arterial Occlusive DiseasePhase 2/3MASCOTNCT00619788
FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study
A Phase 2/3 study testing 4.0-5.0mm AngioSculpt Scoring Balloon Catheter in people with Peripheral Arterial Occlusive Disease, run by Flanders Medical Research Program at 3 sites in 2 countries.
Trial summary
This investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use in a controlled clinical investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- 4.0-5.0mm AngioSculpt Scoring Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2008to Oct 2009
- 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
- Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries (primarily superficial femoral arteries - SFA)
- Length of lesion >5 cm or 2 times the AngioSculpt balloon length (whichever is longer)
- Reference vessel diameter should be 4.0-6.0 mm
- Life altering claudication or critical limb ischemia (Rutherford 3-5)
- No untreated inflow-limiting arterial lesions
- At least single vessel run-off until the ankle
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- The patient must be > 18 years.
- Life-expectancy of more than 12 months
- The subject or legal guardian has been informed of the nature of the evaluation; agrees to its provisions and has signed informed consent
- The patient is capable to follow all evaluation requirements.
Who cannot join
- Patient refusing treatment
- The reference segment diameter is not suitable for available catheter design
- Length of lesion is ≥5 cm or requires more than two overlapping AngioSculpt balloon inflations (whichever is longer) to cover the entire lesion (however, more than two inflations are permitted within an acceptable lesion length)
- The patient has a known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
- The patient has a history of prior life-threatening contrast media reaction
- The patient is currently enrolled in another investigational device or drug trial
- The patient is currently breast-feeding, pregnant or intends to become pregnant
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Prospective, Multicenter, Non-randomized Clinical Trial Investigating the Safety and Efficacy of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for the Treatment of Femoropopliteal Stenotic Disease.
This investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use in a controlled clinical investigation.
The scoring balloon is a semi-compliant balloon encircled by 3 spiral struts with a nitinol scoring element, which theoretically provides targeted scoring of lesions, by concentrating the dilation force thus minimizing barotrauma, elastic recoil and uncontrolled dissection. This may improve the outcome of the intervention and reduce the number of stents required.
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- 4.0-5.0mm AngioSculpt Scoring Balloon Catheter
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4.0-5.0mm AngioSculpt Scoring Balloon CatheterDevice
The AngioSculpt Scoring Balloon Catheter is a line of innovative angioplasty catheters comprising an angioplasty balloon surrounded by a unique system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use Receives: Device: 4.0-5.0mm AngioSculpt Scoring Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication Free Survival at 1 month post-procedure (complications = major amputations defined as amputations at or above the ankle, any cause of death and TLR)
Measured: 1 month
Secondary outcomes (1)
patency of the target lesion. Primary patency is defined as the absence of: a) target lesion revascularization (TLR); b) major amputation due to lesion restenosis or occlusion; c) conversion to bypass surgery and d) untreated significant stenosis on CFDU
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 posted21 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flanders Medical Research Program
- Sponsor type
- Research network
- Collaborators
- AngioScore, Inc.
- Investigators
- Patrick Peeters, MD, Principal investigator, Imelda Hospital, Bonheiden, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619788
- Sponsor's protocol ID
- FMRP-003
- Acronym
- MASCOT
- Status last verified
- Jul 2010
- First submitted
- 7 Feb 2008
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-randomized Clinical Trial Investigating the Safety and Efficacy of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for the Treatment of Femoropopliteal Stenotic Disease.
- ClinicalTrials.gov ID
- NCT00619788
- Acronym / sponsor ID
- MASCOT / FMRP-003
- Conditions
- Peripheral Arterial Occlusive Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Flanders Medical Research ProgramResearch network
- Collaborators
- AngioScore, Inc.
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Feb 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 investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use in a controlled clinical investigation.
The scoring balloon is a semi-compliant balloon encircled by 3 spiral struts with a nitinol scoring element, which theoretically provides targeted scoring of lesions, by concentrating the dilation force thus minimizing barotrauma, elastic recoil and uncontrolled dissection. This may improve the outcome of the intervention and reduce the number of stents required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: 4.0-5.0mm AngioSculpt Scoring Balloon CatheterPatients receiving 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries (primarily superficial femoral arteries - SFA)
- Length of lesion >5 cm or 2 times the AngioSculpt balloon length (whichever is longer)
- Reference vessel diameter should be 4.0-6.0 mm
- Life altering claudication or critical limb ischemia (Rutherford 3-5)
- No untreated inflow-limiting arterial lesions
Key exclusion criteria (7 listed)
- Patient refusing treatment
- The reference segment diameter is not suitable for available catheter design
- Length of lesion is ≥5 cm or requires more than two overlapping AngioSculpt balloon inflations (whichever is longer) to cover the entire lesion (however, more than two inflations are permitted within an acceptable lesion length)
- The patient has a known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
- The patient has a history of prior life-threatening contrast media reaction
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 |
|---|---|---|
| 4.0-5.0mm AngioSculpt Scoring Balloon CatheterThe AngioSculpt Scoring Balloon Catheter is a line of innovative angioplasty catheters comprising an angioplasty balloon surrounded by a unique system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands. | Device | 1 |
Primary outcome
Complication Free Survival at 1 month post-procedure (complications = major amputations defined as amputations at or above the ankle, any cause of death and TLR)
Time frame: 1 month
1 secondary outcome
patency of the target lesion. Primary patency is defined as the absence of: a) target lesion revascularization (TLR); b) major amputation due to lesion restenosis or occlusion; c) conversion to bypass surgery and d) untreated significant stenosis on CFDU
Time frame: 12 months
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 5 Jul 2010.
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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.
Patrick Peeters, MD principal investigator
Imelda Hospital, Bonheiden, Belgium
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 4.0-5.0mm AngioSculpt Scoring Balloon Catheter in people with Peripheral Arterial Occlusive Disease, run by Flanders Medical Research Program at 3 sites in 2 countries.
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 10 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 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, 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?
Complication Free Survival at 1 month post-procedure (complications = major amputations defined as amputations at or above the ankle, any cause of death and TLR) (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 5 Jul 2010.