Peripheral Vascular DiseasePhase 2/3NCT00881257
Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
A Phase 2/3 study testing GRST Peripheral Catheter System in people with Peripheral Vascular Disease, run by Vessix Vascular, Inc at 2 sites in Germany.
Trial summary
The objective of this clinical investigation is to evaluate the safety and efficacy of the Minnow Medical GRST™ Peripheral Catheter System in the treatment of de novo lesions in the superficial femoral artery (SFA) or the popliteal artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- GRST Peripheral Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2007to May 2010
- 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
- Patient is ≥18 of age.
- Patient is Rutherford category 2-4.
- De novo single lesion with a diameter stenosis (%DS) of ≥50%
- Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of <99%.
- Target lesion stenosis has a length of ≤100 mm based on visual assessment.
- Target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment.
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- Angiographic evidence of distal runoff defined as minimum one patent tibial artery with a straight flow to the foot.
- Patient is willing and able to provide written informed consent prior to any study specific procedure.
- Patient is willing and able to comply with specified follow-up evaluations at the specified times.
Who cannot join
- Prior PTA in the intended target lesion including 10 mm proximal or distal from the intended treatment area.
- Evidence of thrombus in the target vessel.
- Prior ipsilateral or contralateral lower limb arterial bypass.
- Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure.
- Target lesion is severely calcified.
- Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Heparin, contrast agents (that cannot be adequately pre-medicated).
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- Any planned surgery within 30 days of the study procedure.
- Renal failure (serum creatinine > 2.0 mg/dL).
- Female with childbearing potential without a negative pregnancy test.
- Patient has had an organ transplant.
- Patient is currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the endpoints of this study.
- In the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Hamburg University Cardiovascular Center
Hamburg, 22527
About this study
The objective of this clinical investigation is to evaluate the safety and efficacy of the Minnow Medical GRST™ Peripheral Catheter System in the treatment of de novo lesions in the superficial femoral artery (SFA) or the popliteal artery.
- Conditions
- Peripheral Vascular Disease
- Being tested
- GRST Peripheral Catheter System
- Keywords
- Peripheral Vascular Disease, Peripheral Artery Disease, Radiofrequency
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRST Peripheral Catheter SystemDevice
Treatment to dilate stenoses and reduce plaque in treated vessels
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GRST Peripheral Catheter System Receives: Device: GRST Peripheral Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Clinical Events Rate
Measured: Up to 30 days
Secondary outcomes (5)
Binary Restenosis
Measured: 30 days, 3 months, 6 months and 12 months
Target Lesion Revascularization
Measured: 30 days, 3 months, 6 months and 12 months
Amputation Rate
Measured: 30 days, 3 months, 6 months, and 12 months
Technical Success
Measured: Treatment
Serious Adverse Events rate, including Major Adverse Clinical Events
Measured: 30 days, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startAug 2007
- Primary completionNov 2009
- Study completionMay 2010
Why it stopped: Data was inconclusive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vessix Vascular, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Krankenberg, MD, Principal investigator, Hamburg University Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881257
- Sponsor's protocol ID
- DR0148
- Status last verified
- Jun 2013
- First submitted
- 13 Apr 2009
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Assessment of the Safety and Efficacy of the Minnow Medical GRST™ Peripheral Catheter System
- ClinicalTrials.gov ID
- NCT00881257
- Acronym / sponsor ID
- DR0148
- Conditions
- Peripheral Vascular Disease
- Keywords
- Peripheral Vascular Disease, Peripheral Artery Disease, Radiofrequency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data was inconclusive
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Vessix Vascular, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 Apr 2009 (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 objective of this clinical investigation is to evaluate the safety and efficacy of the Minnow Medical GRST™ Peripheral Catheter System in the treatment of de novo lesions in the superficial femoral artery (SFA) or the popliteal artery.
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: GRST Peripheral Catheter SystemGRST Peripheral Catheter System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is ≥18 of age.
- Patient is Rutherford category 2-4.
- De novo single lesion with a diameter stenosis (%DS) of ≥50%
- Target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of <99%.
- Target lesion stenosis has a length of ≤100 mm based on visual assessment.
Key exclusion criteria (12 listed)
- Prior PTA in the intended target lesion including 10 mm proximal or distal from the intended treatment area.
- Evidence of thrombus in the target vessel.
- Prior ipsilateral or contralateral lower limb arterial bypass.
- Treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure.
- Target lesion is severely calcified.
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 |
|---|---|---|
| GRST Peripheral Catheter SystemTreatment to dilate stenoses and reduce plaque in treated vessels | Device | 1 |
Primary outcome
Major Adverse Clinical Events Rate
Time frame: Up to 30 days
5 secondary outcomes
Binary Restenosis
Time frame: 30 days, 3 months, 6 months and 12 months
Target Lesion Revascularization
Time frame: 30 days, 3 months, 6 months and 12 months
Amputation Rate
Time frame: 30 days, 3 months, 6 months, and 12 months
Technical Success
Time frame: Treatment
Serious Adverse Events rate, including Major Adverse Clinical Events
Time frame: 30 days, 3 months, 6 months, and 12 months
Results and safety
The study was stopped early (reason given: Data was inconclusive). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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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.
Hans Krankenberg, MD principal investigator
Hamburg University Cardiovascular Center
2 sites 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 GRST Peripheral Catheter System in people with Peripheral Vascular Disease, run by Vessix Vascular, Inc at 2 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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 was stopped early (reason given: Data was inconclusive). Results are not available in the source record.
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?
Major Adverse Clinical Events Rate (time frame: Up to 30 days). 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 20 Jun 2013.