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Safety and Effectiveness Study of Eximo's CathiTM Atherectomy Device for PAD Treatment

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ClinicalTrials.gov Identifier: NCT02556255
Recruitment Status : Unknown
Verified September 2015 by Eximo Medical Ltd..
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
KCRI
Information provided by (Responsible Party):
Eximo Medical Ltd.

Brief Summary:
The aim of the study is to assess the safety and efficacy of the use of the Eximo's CathiTM hybrid catheter in subjects affected with Peripheral Artery Disease (PAD) in lower extremity arteries.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: CathiTM Atherectomy Hybrid Catheter Phase 1 Phase 2

Detailed Description:

This is a prospective, single-arm, multi-center, international, open-label, non-randomized clinical study.

All enrolled subjects will undergo atherectomy procedure, during which the CathiTM catheter will be used to perform atherectomy in target lesion, followed by any other adjunctive therapy (balloon and/or stent etc.). The procedure will be done according to standard hospital procedure for atherectomy. The steps of the operation before and after the operating of the CathiTM device are routinely used practice and will be done according to local practice at each hospital. For the post-atherectomy stage, as an adjunctive therapy in the procedure, any approved device may be used (balloon and/or stent etc.).

Subjects will then be followed for 12 months after the procedure.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness Evaluation of Eximo's CathiTM, a Hybrid Atherectomy Device, in Subjects Affected With PAD
Study Start Date : October 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CathiTM Atherectomy Hybrid Catheter
Percutaneous Transluminal Atherectomy (PTA) catheter for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD)
Device: CathiTM Atherectomy Hybrid Catheter
Percutaneous Transluminal Atherectomy (PTA) catheter for treatment of infrainguinal arteries in patients with Peripheral Artery Disease (PAD)




Primary Outcome Measures :
  1. Freedom from Major Adverse Events [ Time Frame: 30 days post procedure ]
    1. Need for emergency surgical revascularization of the target limb
    2. Unplanned target limb amputation above the ankle
    3. Clinically driven Target Lesion Revascularization (TLR)
    4. Cardiovascular related deaths

  2. Freedom from Device/Procedure Related Adverse Events [ Time Frame: Perioperative (the duration of hospital stay until discharge), an expected average of 2 days ]
    1. Clinically Significant Perforations requiring intervention
    2. Clinically Significant Dissections requiring intervention
    3. Clinically Significant Embolus requiring intervention
    4. Clinically Pseudo-aneurysm requiring intervention

  3. Technical success rate: the ability of the CathiTM catheter to cross the target lesion stenosis over the wire. [ Time Frame: intraoperative ]
    The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy.


Secondary Outcome Measures :
  1. Freedom from Device/Procedure Related Adverse Events [ Time Frame: Perioperative (the duration of hospital stay until discharge), an expected average of 2 days ]
    1. Emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator
    2. Flow limitation dissection

  2. Freedom from Device/Procedure Related Adverse Events [ Time Frame: 30 days post procedure ]
    1. Clinically Significant Dissections requiring intervention
    2. Clinically Significant Embolus requiring intervention
    3. Clinically Pseudo-aneurysm requiring intervention

  3. The ability of the CathiTM catheter to achieve a post-intervention residual diameter stenosis of <30% with adjunctive therapy as assessed by quantitative Duplex ultrasonography [ Time Frame: 30 days, 6 months and 12 months post procedure ]
  4. Improved Ankle-Brachial Index (ABI) post CathiTM device procedure compared to baseline [ Time Frame: 30 days, 6 months and 12 months post procedure ]
  5. Improved Rutherford Classification post CathiTM device procedure compared to baseline. [ Time Frame: 30 days, 6 months and 12 months post procedure ]
  6. Improved Grade of Walking Impairment Questionnaire (WIQ) post CathiTM device procedure compared to baseline. [ Time Frame: 30 days, 6 months and 12 months post procedure ]


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. Subject is ≥ 18 years old.
  2. Subject is a candidate for endovascular intervention for peripheral artery disease in the lower extremities.
  3. Documented symptomatic atherosclerotic peripheral artery disease Rutherford Classification 2-4.
  4. Reference vessel lumen diameter proximal to target lesion is estimated to be >150% of the outer diameter of the CathiTM, based on CT Angiogram.
  5. Subject has infrainguinal target lesion(s) with stenosis (is estimated to be ≥70% based on CT angiogram), restenosis, in-stent restenosis or occlusions.
  6. The target lesion blood flow diameter is estimated to be at least 0.5 mm smaller than Eximo catheter's outer diameter based on CT Angiogram.
  7. At least one patent tibial run-off vessel at baseline.
  8. Subject is capable and willing to comply with, and be present at, the follow-up clinic visits at least at the 30 days visit, with the intention to arrive to the 6 months and 12 months follow-up visits.
  9. Subject has undergone standard of care and routine tests for a procedure like PAD intervention, including WBC profile, coagulation status and kidney function and found to be suitable.
  10. Subject is able and willing to sign a written informed consent form (ICF).

Intraoperative inclusion criteria (by fluoroscopy angiogram):

  1. Reference vessel lumen diameter proximal to target lesion is >150% of the outer diameter of the CathiTM.
  2. The target lesion blood flow diameter is at least 0.5 mm smaller than Eximo catheter's outer diameter.
  3. Target lesion has been crossed with a guidewire.

Exclusion Criteria:

  1. Target lesion is in or above inguinal level arteries.
  2. Target lesion length >25 cm.
  3. Rutherford Class < 2 or > 4
  4. Severe calcification in the target lesion
  5. Target lesion is a thrombus only for which an embolic protection device is not intended to be used.
  6. Target lesion stenosis < 70%
  7. Reference vessel lumen diameter proximal to target lesion is estimated to be ≤150% of the outer diameter of the CathiTM based on CT Angiogram.
  8. Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure.
  9. Planned endovascular or surgical procedure 30 days after the index procedure.
  10. Intent to use other atherectomy device in the same procedure.
  11. Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure.
  12. Subjects with active infections whether they are being currently treated or not.
  13. Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
  14. Evidence or history of aneurysmal target vessel within the past 2 months.
  15. History of heparin-induced thrombocytopenia (HIT).
  16. Any clinical and/or angiographic complication attributed to the use of another device prior to the study procedure.
  17. Any thrombolytic therapy within 2 weeks of the index procedure.
  18. History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
  19. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  20. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
  21. Serious illness that may affect subject compliance to protocol.
  22. Participating in other clinical study that may interfere with study's primary and secondary endpoints.
  23. Any issue that in the judgment of the investigator, may affect the results of the study.
  24. Subject is pregnant or planning to become pregnant during the study period.

Intraoperative exclusion criteria (by fluoroscopy angiogram):

  1. Total occlusion of the Target lesion that cannot be crossed by GW.
  2. Reference vessel lumen diameter proximal to target lesion is ≤150% of the outer diameter of the CathiTM.
  3. An embolic protection device cannot be used for a lesion that is only made of thrombus.

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): NCT02556255


Contacts
Contact: Yossi Muncher, Ph.D., MBA +972 8 630 7634 yossim@eximomedical.com
Contact: Oshrat Cohen +972 8 630 7634 oshratc@eximomedical.com

Sponsors and Collaborators
Eximo Medical Ltd.
KCRI
Investigators
Study Director: Yossi Muncher, Ph.D., MBA Eximo Medical

Responsible Party: Eximo Medical Ltd.
ClinicalTrials.gov Identifier: NCT02556255     History of Changes
Other Study ID Numbers: EX-PAD-01
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Eximo Medical Ltd.:
Peripheral Arterial Disease
Peripheral Artery Disease
PAD
Atherosclerosis
Arterial Occlusive Diseases
Peripheral Vascular Diseases
PVD

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases