Critical Limb IschemiaPhase 4CLIMBNCT00459888

Cryoplasty CLIMB-registry

A Phase 4 study testing PolarCath Peripheral Dilatation System (Boston Scientific) in people with Critical Limb Ischemia and Peripheral Arterial Occlusive 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

In 5 Belgian hospitals, the data of 100 CLI-patients receiving the cryoplasty technique to treat their infrapopliteal arterial lesions will be collected. The treatment occurs strictly according the "Instructions For Use" of the CE-approved device (PolarCath Peripheral Dilatation System, Boston Scientific) and only… Read more about this study

Who is it for?: Any age
Conditions the study is for: Critical Limb Ischemia, Peripheral Arterial Occlusive Disease
What is being tested?: PolarCath Peripheral Dilatation System (Boston Scientific)
Type of treatment: Medical device
How many people: 100 participants
Where: 4 sitesBelgium
Study dates: May 2007to May 2009
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Symptomatic CLI male or female patients with at least 1 atherosclerotic diseased infrapopliteal artery. If patients present with more than 1 diseased vessel, only the vessel with the best distal run-off providing the foot with blood, will be assessed following treatment with the PolarCath Peripheral Dilatation System (Boston Scientific) and analysed for registry purposes.
Patients will be considered eligible for inclusion into the registry if satisfying the product DFU specifications.

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

Imelda Hospital
Bonheiden, 2820
AZ Sint-Blasius
Dendermonde, 9200
ZOL Campus Sint-Jan
Genk, 3600
University Hospital
Ghent, 9000

Other trials in Belgium

About this study

Official title: CLIMB Prospective Multicenter Registry Evaluating the Use of the PolarCath Peripheral Dilatation System (Boston Scientific) in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia (Rutherford 4 and 5).

Conditions: Critical Limb Ischemia, Peripheral Arterial Occlusive Disease
Being tested: PolarCath Peripheral Dilatation System (Boston Scientific)
Keywords: CLI, Critical Limb Ischemia, Infrapopliteal, Cryoplasty
Medical subject headings: Chronic Limb-Threatening Ischemia, Peripheral Arterial Occlusive Disease 1

What participants receive

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

PolarCath Peripheral Dilatation System (Boston Scientific)Device

What is being measured

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

Clinical patency
Measured: 12 months

Secondary outcomes (7)

Technical success
Measured: procedure
angiographic outcomes for the subgroup of patients in which made available.
Measured: 12 months
Primary patency rate
Measured: 12 months
Limb-salvage rate
Measured: 12 months
Serious adverse events
Measured: 12 months
Clinical success (improvement of Rutherford classification)
Measured: 12 months
Health Economics assessment
Measured: 12 months

Timeline

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

May 2007May 2009

First posted13 Apr 2007 (estimated)
Study startMay 2007
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Critical Limb IschemiaStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00459888
Sponsor's protocol ID: FMRP-001
Acronym: CLIMB
Status last verified: Jul 2010
First submitted: 12 Apr 2007
Last updated: 5 Jul 2010
Results posted: No
Data monitoring committee: No

Publications

Bosiers M, Deloose K, Vermassen F, Schroe H, Lauwers G, Lansinck W, Peeters P. The use of the cryoplasty technique in the treatment of infrapopliteal lesions for Critical Limb Ischemia patients in a routine hospital setting: one-year outcome of the Cryoplasty CLIMB Registry. J Cardiovasc Surg (Torino). 2010 Apr;51(2):193-202.
PubMed 20354489

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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Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
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Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
RecruitingEarly Phase 1
Nutrition in Patient With Critical Limb Ischemia
Critical Limb Ischemia, Malnutrition

All Critical Limb Ischemia trials

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: CLIMB Prospective Multicenter Registry Evaluating the Use of the PolarCath Peripheral Dilatation System (Boston Scientific) in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia (Rutherford 4 and 5).
ClinicalTrials.gov ID: NCT00459888
Acronym / sponsor ID: CLIMB / FMRP-001
Conditions: Critical Limb Ischemia, Peripheral Arterial Occlusive Disease
Keywords: CLI, Critical Limb Ischemia, Infrapopliteal, Cryoplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (estimated)
Lead sponsor: Flanders Medical Research ProgramResearch network
Study start: May 2007
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 13 Apr 2007 (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: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Symptomatic CLI male or female patients with at least 1 atherosclerotic diseased infrapopliteal artery. If patients present with more than 1 diseased vessel, only the vessel with the best distal run-off providing the foot with blood, will be assessed following treatment with the PolarCath Peripheral Dilatation System (Boston Scientific) and analysed for registry purposes.
Patients will be considered eligible for inclusion into the registry if satisfying the product DFU specifications.

Key exclusion criteria (0 listed)

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
PolarCath Peripheral Dilatation System (Boston Scientific)	Device	–

Primary outcome

Clinical patency
Time frame: 12 months

7 secondary outcomes

Technical success
Time frame: procedure
angiographic outcomes for the subgroup of patients in which made available.
Time frame: 12 months
Primary patency rate
Time frame: 12 months
Limb-salvage rate
Time frame: 12 months
Serious adverse events
Time frame: 12 months
Clinical success (improvement of Rutherford classification)
Time frame: 12 months
Health Economics assessment
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.
Derived from this study: PubMed 20354489Bosiers M, Deloose K, Vermassen F, Schroe H, Lauwers G, Lansinck W, Peeters P. The use of the cryoplasty technique in the treatment of infrapopliteal lesions for Critical Limb Ischemia patients in a routine hospital setting: one-year outcome of the Cryoplasty CLIMB Registry. J Cardiovasc Surg (Torino). 2010 Apr;51(2):193-202.

Related trials for Critical Limb Ischemia

Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
RecruitingEarly Phase 1
Nutrition in Patient With Critical Limb Ischemia
Critical Limb Ischemia, Malnutrition

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.

Marc Bosiers, MD principal investigator

AZ Sint-Blasius, Dendermonde, Belgium

Frank Vermassen, MD principal investigator

University Hospital Ghent, Belgium

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

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 0 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 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?

Clinical 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 NCT00459888, which also lists 1 linked publication.

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.