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ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study (BTK PMS)

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ClinicalTrials.gov Identifier: NCT03395236
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation

Brief Summary:
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the knee" popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in Rutherford-Becker Classification (RCC) 3, 4 and 5 patient populations. This study will be conducted in Europe across up to 10 centers in up to 75 subjects. Office visits will occur at 30 days, 6, 12, and 24 months post-index procedure.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Combination Product: StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ProspectIve, MuLti-Center Study to EvaLUate TreatMent of Subjects With OcclusivE Disease With a Novel PAcliTazel-CoatEd Angioplasty Balloon in Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: Treatment
StellarexTM 0.014 OTW Drug-coated Angioplasty Balloon (Stellarex Balloon)
Combination Product: StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon
The Stellarex balloon (0.014") is indicated for the treatment of de-novo or re-stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency.




Primary Outcome Measures :
  1. Primary Safety Endpoint-Composite Major Adverse Limb Events (MALE) + perioperative death (POD); the composite is the number of participants who do not have MALE or POD at 30 days [ Time Frame: 30 days ]
    Major Adverse Limb Event (MALE) is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major re-intervention is defined as creation of a new surgical bypass graft, the use of thrombectomy or thrombolysis or a major surgical graft revision such as a jump graft or an interposition graft. This is a single endpoint as it is a composite only subjects who do not have MALE or POD will be counted toward this endpoint MALE is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major re-intervention is defined as creation of a new surgical bypass graft, the use of thrombectomy or thrombolysis or a major surgical graft revision such as a jump graft or an interposition graft. POD is all-cause death through 30 days of the index procedure.

  2. Primary Performance Endpoint-Composite patency + limb salvage through 6 months; the composite is the number of participants with patency and limb salvage at 6 months [ Time Frame: 6 months ]

    Patency defined as freedom from occluded target lesions (flow/no flow) verified by duplex ultrasound and clinically-driven target lesion revascularization (CD-TLR) Freedom from major amputation in the Target Limb

    This is a single endpoint as only subjects with both patency and limb salvage will be considered for this endpoint.



Secondary Outcome Measures :
  1. Major adverse event (MAE) rate at 6,12, and 24 months post index procedure [ Time Frame: 6, 12, and 24 months ]
    Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR

  2. Rate of CD-TLR at 6, 12 and 24 months [ Time Frame: 6, 12 and 24 months ]
  3. Patency rate at 6, 12 and 24 months, defined as the presence of target lesion flow (absence of occlusion or no flow) as determined by Duplex Ultrasound (DUS) and freedom from CD-TLR [ Time Frame: 6, 12 and 24 months ]
  4. Rate of procedural complications defined as occurrence of all-cause death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure [ Time Frame: through study completion, approximately 3 years ]
  5. Rate of device or procedure related death at 30 days [ Time Frame: 30 days ]
  6. Rate of major target limb amputation at 6, 12, 24 months post-procedure [ Time Frame: 6, 12, and 24 months ]
  7. Rate of clinically driven target vessel revascularization through 6, 12 and 24 months [ Time Frame: 6, 12 and 24 months ]
  8. Lesion success: [ Time Frame: Through study completion, approximately 3 years ]
    achievement of a final in-lesion residual diameter stenosis of <50% (as determined by the angiographic core laboratory), using allowed pretreatment devices after guidewire passage through the lesion

  9. Technical success: [ Time Frame: Through study completion, approximately 3 years ]
    achievement of a final in-lesion residual diameter stenosis of <50% (as determined by the angiographic core laboratory), using the Stellarex 0.014" Drug-Coated Balloon without a device malfunction after a guidewire passage through the l

  10. Change in waveforms/TcPO2 from pre-procedure to 30 days, 6, 12, and 24 months [ Time Frame: 30 days, 6, 12, and 24 months ]
  11. Change in ankle-brachial index (ABI) from pre-procedure to 30 days, 6, 12, and 24 months [ Time Frame: 30 days, 6, 12, and 24 months ]
  12. Change in toe pressures (TP) from pre-procedure to 30 days, 6, 12, and 24 months [ Time Frame: 30 days, 6, 12, and 24 months ]
  13. Change in Rutherford-Becker Classification (RCC) from pre-procedure to 30 days, 6, 12, and 24 months [ Time Frame: 30 days, 6, 12, and 24 months ]
  14. Change in EQ-5D from pre-procedure to 30 days, 6, 12, and 24 months [ Time Frame: 30 days, 6, 12, and 24 months ]
  15. In RCC 5 subjects, percentage of wounds healed from baseline to 30 days, 6 and 12 months post-procedure as reported by the Investigator at the Investigative site [ Time Frame: 30 days, 6 and 12 months ]


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:

  • Subjects intended to be treated with the Stellarex 0.014" Drug-Coated Balloon (DCB) for de-novo or restenotic lesions in native "below the knee" popliteal (P3) segment and infra-popliteal arteries ending 1 cm above the ankle, as per the Instruction for Use (IFU)
  • Rutherford-Becker clinical category classification (RCC) 3 patients with claudication or RCC 4 or 5 subjects with documented Critical Limb Ischemia (CLI) defined as:
  • RCC 3 subjects: subjects with severe claudication
  • RCC 4 subjects: persistent, recurring ischemic rest pain requiring analgesia for at least two weeks and ankle systolic pressure <70 mmHg, and/or toe systolic pressure <50 mmHg; or
  • RCC 5 subjects: minor tissue loss of the foot or toes and ankle systolic pressure <70 mmHg and/or toe systolic pressure <50 mmHg; or
  • RCC 4 or 5 subjects with non-compressible vessels: absent pedal pulses with a flat or near flat waveform
  • Age ≥18 years old
  • Reconstitution of the target vessel at the ankle and run-off into a patent dorsalis pedis or plantar arteries defined as <50% stenosis by visual estimate
  • Is able and willing to provide written informed consent and comply with all required follow-up evaluations within the defined follow-up visit windows prior to enrollment in the study
  • Life expectancy > 1 year

Exclusion Criteria:

  • Subjects with any medical condition that would make him/her inappropriate for treatment with the Stellarex balloon as per the Instructions for Use (IFU) or in the opinion of the investigator
  • Has impaired renal function defined as serum creatinine >2.5mg/dl that cannot be adequately pre-treated or subjects on dialysis
  • Subjects already enrolled in other investigational (interventional) studies that would interfere with study endpoints
  • Subjects that in the judgment of the investigator would require treatment of the contralateral limb within 3 days prior to the index procedure or 30 days after. Note: Unless contralateral treatment is required to facilitate adequate access to the target lesion (e.g. contralateral iliac)
  • Previous or planned surgical or catheter-based procedure within 3 days before or 30 days after the index procedure. Note: This excludes successful inflow artery treatment within the same hospitalization. Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without major vascular complication (e.g. absence of flow-limiting dissection, embolic event). These inflow arteries must be treated without the need for laser, atherectomy, thrombectomy, cryoplasty, brachytherapy and cutting/scoring balloons. Treatment with a Stellarex DCB of the inflow lesion, if according to its intended use, is allowed
  • Prior endovascular treatment of the target lesion within three (3) months of the index procedure
  • Prior stent placement in the target lesion(s)
  • Single focal lesion < 4cm in length in the absence of additional treatable popliteal or infra-popliteal lesions
  • Subjects confined to bed that are completely non-ambulatory
  • For RCC 5 subjects; Non-arterial ulcers such as venous ulcers neurotrophic ulcers, heel pressure ulcers, ulcers potentially involving calcaneus region or ulcers in the proximal one-half of the foot or higher (from mid-foot and higher going up the leg)
  • Subjects scheduled to undergo a planned major amputation
  • Presence of concentric calcification that precludes adequate vessel preparation per IFU

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): NCT03395236


Contacts
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Contact: Anneleen De Cock +32 470 59 24 78 anneleen.de.cock@bv.spnc.com

Locations
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Germany
RoMed Klinikum Rosenheim Recruiting
Rosenheim, Germany
Contact: Gunnar Tepe, MD         
Sponsors and Collaborators
Spectranetics Corporation

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Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT03395236     History of Changes
Other Study ID Numbers: D037012
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

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