Peripheral Arterial DiseasePhase 4NCT01783600

NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions

A Phase 4 study testing NanoCross .014 balloon catheter in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective, non-randomised, controlled investigation for the treatment of patients with critical limb ischemia (Rutherford 4-5) due to the presence of lesions… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Peripheral Arterial Disease
What is being tested?: NanoCross .014 balloon catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 4 sitesBelgium
Study dates: Jan 2013to Mar 2016
Phase: Phase 4
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient is >18 years old
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Patient has a projected life-expectancy of at least 12 months
Patient is eligible for treatment with the NanoCrossTM .014 balloon catheter (Covidien)

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Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries,suitable for endovascular therapy
Total target lesion length minimally 100mm
Target vessel diameter visually estimated to be >1.5mm and <4.0mm
Guidewire and delivery system successfully traversed lesion
At least one non-occluded crural artery with angiographically documented run- off to the foot.

Who cannot join

Patient refusing treatment
The reference segment diameter is not suitable for the available balloon design
Untreated flow-limiting inflow lesions
Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
Aneurysm in the target vessel

Show all 18Show fewer

Target lesion has severe calcification as determined by physician's discretion
Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
Major distal amputation (above the transmetatarsal) in the study limb or non- study limb
Septicemia or bacteremia
Any previously known coagulation disorder, including hypercoagulability
Contraindication to anticoagulation or antiplatelet therapy
Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
Currently participating in another clinical research trial
Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
Target lesion access not performed by transfemoral approach.

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

OLV Aalst
Alast, 9300
Imelda Hospital
Bonheiden, 2820
AZ Sint-Blasius
Dendermonde, 9200
RZ Heilig Hart Tienen
Tienen, 3300

Other trials in Belgium

About this study

Conditions: Peripheral Arterial Disease
Being tested: NanoCross .014 balloon catheter
Keywords: Peripheral Arterial Disease, Infrapopliteal lesions, balloon catheter
Medical subject headings: Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NanoCross .014 balloon catheterDevice

Study groups in NCT01783600
Study group	Role	What they receive
NanoCross .014 balloon catheter	Other	NanoCross .014 balloon catheter Receives: Device: NanoCross .014 balloon catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

primary Patency
Primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the 12-month follow-up
Measured: 12 Months

Secondary outcomes (8)

Technical success
Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
Measured: Day 0 (=procedure date)
Hemodynamic primary patency
Hemodynamic primary patency rate at 1 and 6-month follow-up. Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up.
Measured: 1 and 6 months follow-up
Limb-salvage rate
Limb-salvage rate at all follow-up visits, defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot).
Measured: 1, 6 and 12 months follow-up
Primary assisted patency rate
Primary assisted patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
Measured: 1, 6, 12-month follow-up
Secondary patency rate
Secondary patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
Measured: 1, 6, 12-month follow-up
Target lesion revascularization
Target lesion revascularization (TLR) is defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.
Measured: 1 day, 1 month, 6 month and 12 month follow-up
Clinical success at follow-up
Clinical success at follow-up is defined as an improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Measured: 1 day and 1, 6, 12-month follow-up
Number of patients with Serious Adverse Events (SAE) as a measure of safety
Serious adverse events as defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization
Measured: 1 day, 1 month, 6 month and 12 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Mar 2016

First posted5 Feb 2013 (estimated)
Study startJan 2013
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Peripheral Arterial 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01783600
Sponsor's protocol ID: FMRP-111125
Status last verified: Aug 2016
First submitted: 25 Jan 2013
Last updated: 11 Aug 2016
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Arterial Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions
ClinicalTrials.gov ID: NCT01783600
Acronym / sponsor ID: FMRP-111125
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease, Infrapopliteal lesions, balloon catheter
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Flanders Medical Research ProgramResearch network
Study start: Jan 2013
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 5 Feb 2013 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NanoCross .014 balloon catheter	Other	Device: NanoCross .014 balloon catheterNanoCross .014 balloon catheter

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient is >18 years old
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Patient has a projected life-expectancy of at least 12 months

Key exclusion criteria (18 listed)

Patient refusing treatment
The reference segment diameter is not suitable for the available balloon design
Untreated flow-limiting inflow lesions
Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
Any previous surgery in the target vessel (including prior ipsilateral crural bypass)

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
NanoCross .014 balloon catheter	Device	NanoCross .014 balloon catheter

Primary outcome

primary Patency
Time frame: 12 Months
Primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the 12-month follow-up

8 secondary outcomes

Technical success
Time frame: Day 0 (=procedure date)
Hemodynamic primary patency
Time frame: 1 and 6 months follow-up
Limb-salvage rate
Time frame: 1, 6 and 12 months follow-up
Primary assisted patency rate
Time frame: 1, 6, 12-month follow-up
Secondary patency rate
Time frame: 1, 6, 12-month follow-up
Target lesion revascularization
Time frame: 1 day, 1 month, 6 month and 12 month follow-up
Clinical success at follow-up
Time frame: 1 day and 1, 6, 12-month follow-up
Number of patients with Serious Adverse Events (SAE) as a measure of safety
Time frame: 1 day, 1 month, 6 month and 12 month follow-up

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 11 Aug 2016.

Related trials for Peripheral Arterial Disease

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Active, not recruiting
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RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
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Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NanoCross .014 balloon catheter in people with Peripheral Arterial Disease, run by Flanders Medical Research Program at 4 sites in Belgium.

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 12 inclusion and 18 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 11 Aug 2016. 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 Belgium. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

primary Patency (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01783600.

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 11 Aug 2016.