Peripheral Arterial DiseaseMODIFYNCT03268018
ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study
A study testing Laser induced pressure wave calcium modification in people with Peripheral Arterial Disease, run by Spectranetics Corporation at 2 sites in Belgium.
Trial summary
The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Laser induced pressure wave calcium modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesBelgium
- Study dates
- 7 Jun 2017to 18 Mar 2018
- 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
- Patient age ≥ 18 years
- Patient agrees to participate and comply with the protocol by signing an Ethics Committee approved consent form
- Peripheral arterial disease with a documented Rutherford Class 2-5 and
- a resting ankle-brachial index (ABI) of <0.9 or an abnormal exercise ABI (<0.75) if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a toe brachial index (TBI) <0.7 in target limb;
- or a previous intervention to the target vessels with reoccurrence of symptoms
- Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion to less than 50% diameter stenosis (DS)
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- Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending greater than 1 cm in length
- De novo or restenotic lesion of the SFA, popliteal or infrapopliteal artery
- Minimum reference vessel diameter (RVD) of 2.5mm
- Minimum target lesion length of ≥ 5cm
- At least one patent (<50% stenosed) runoff vessel to the foot
Who cannot join
- Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment)
- Life expectancy < 12 months
- Cerebrovascular accident < 60 days prior to procedure
- Myocardial infarction < 60 days prior to procedure
- Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure
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- Uncontrolled hypercoagulability or history of HIT or HITT syndrome
- Serum creatinine ≥ 2.5 mg/dL tested within a week prior to procedure
- Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint
- Patient is not eligible for bypass surgery or endovascular intervention
- Planned major amputation
- Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoropopliteal, and contralateral below the knee
- Lesion located within a stent or endograft
- Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis ≥ 50% DS that is not successfully treated prior to index procedure
- Target lesion could not be crossed with the guidewire or support catheter
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Onze Lieve Vrouw Ziekenhuis
Aalst, 9300
AZ Sint Blasius
Dendermonde
About this study
The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY Pilot study will evaluate safety and performance measurements.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Laser induced pressure wave calcium modification
- Keywords
- calcium, peripheral arterial disease
- 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.
Laser induced pressure wave calcium modificationDevice
Also called Laser atherectomy
A calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Not described Receives: Device: Laser induced pressure wave calcium modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary performance defined as minimum lumen diameter measured pre-laser atherectomy and post-calcium modification as well as the ability to dilate a previously balloon resistant lesion after calcium modification procedure
Minimum Lumen Diameter (MLD) measured pre-laser atherectomy and post-calcium modification, as measured by angiography and QVA.
The ability to dilate a previously balloon resistant lesion after calcium modification procedure with low pressure balloon inflation.
Measured: Index procedure
Primary safety as defined as major adverse event (MAE) composite of all cause death, target vessel revascularization and major amputation of the target limb.
Safety outcome through 30-day follow-up (MAE composite):
All cause death Target vessel revascularization (TVR) Major amputation of target limb
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start7 Jun 2017
- Primary completion31 Oct 2017
- Study completion18 Mar 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268018
- Sponsor's protocol ID
- D034698
- Acronym
- MODIFY
- Status last verified
- Sep 2018
- First submitted
- 11 Jul 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study
- ClinicalTrials.gov ID
- NCT03268018
- Acronym / sponsor ID
- MODIFY / D034698
- Conditions
- Peripheral Arterial Disease
- Keywords
- calcium, peripheral arterial disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- 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 MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY Pilot study will evaluate safety and performance measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: Laser induced pressure wave calcium modification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient age ≥ 18 years
- Patient agrees to participate and comply with the protocol by signing an Ethics Committee approved consent form
- Peripheral arterial disease with a documented Rutherford Class 2-5 and
- Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion to less than 50% diameter stenosis (DS)
- Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending greater than 1 cm in length
Key exclusion criteria (15 listed)
- Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment)
- Life expectancy < 12 months
- Cerebrovascular accident < 60 days prior to procedure
- Myocardial infarction < 60 days prior to procedure
- Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up
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 |
|---|---|---|
| Laser induced pressure wave calcium modificationAlso: Laser atherectomyA calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes | Device | Single arm |
Primary outcome
Primary performance defined as minimum lumen diameter measured pre-laser atherectomy and post-calcium modification as well as the ability to dilate a previously balloon resistant lesion after calcium modification procedure
Time frame: Index procedure
Minimum Lumen Diameter (MLD) measured pre-laser atherectomy and post-calcium modification, as measured by angiography and QVA. The ability to dilate a previously balloon resistant lesion after calcium modification procedure with low pressure balloon inflation.
Primary safety as defined as major adverse event (MAE) composite of all cause death, target vessel revascularization and major amputation of the target limb.
Time frame: 30 days
Safety outcome through 30-day follow-up (MAE composite): All cause death Target vessel revascularization (TVR) Major amputation of target limb
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 2019.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser induced pressure wave calcium modification in people with Peripheral Arterial Disease, run by Spectranetics Corporation at 2 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 11 inclusion and 15 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 2019. 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 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.
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 performance defined as minimum lumen diameter measured pre-laser atherectomy and post-calcium modification as well as the ability to dilate a previously balloon resistant lesion after calcium modification procedure (time frame: Index procedure). 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 2019.