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ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study (MODIFY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03268018
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Laser induced pressure wave calcium modification Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : March 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single arm Device: Laser induced pressure wave calcium modification
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
Other Name: Laser atherectomy




Primary Outcome Measures :
  1. 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.


  2. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient age ≥ 18 years
  2. Patient agrees to participate and comply with the protocol by signing an Ethics Committee approved consent form
  3. Peripheral arterial disease with a documented Rutherford Class 2-5 and

    1. 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;
    2. or a previous intervention to the target vessels with reoccurrence of symptoms
  4. Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion to less than 50% diameter stenosis (DS)
  5. Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending greater than 1 cm in length
  6. De novo or restenotic lesion of the SFA, popliteal or infrapopliteal artery
  7. Minimum reference vessel diameter (RVD) of 2.5mm
  8. Minimum target lesion length of ≥ 5cm
  9. At least one patent (<50% stenosed) runoff vessel to the foot

Exclusion Criteria:

  1. Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment)
  2. Life expectancy < 12 months
  3. Cerebrovascular accident < 60 days prior to procedure
  4. Myocardial infarction < 60 days prior to procedure
  5. Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up
  6. Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure
  7. Uncontrolled hypercoagulability or history of HIT or HITT syndrome
  8. Serum creatinine ≥ 2.5 mg/dL tested within a week prior to procedure
  9. Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint
  10. Patient is not eligible for bypass surgery or endovascular intervention
  11. Planned major amputation
  12. 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
  13. Lesion located within a stent or endograft
  14. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis ≥ 50% DS that is not successfully treated prior to index procedure
  15. Target lesion could not be crossed with the guidewire or support catheter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268018


Locations
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Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, 9300
AZ Sint Blasius
Dendermonde, Belgium
Sponsors and Collaborators
Spectranetics Corporation

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Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT03268018    
Other Study ID Numbers: D034698
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spectranetics Corporation:
calcium
peripheral arterial disease
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents