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DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes

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: NCT02469532
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Mercator MedSystems, Inc.

Brief Summary:
This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Device: Balloon Angioplasty Device: Atherectomy System

Detailed Description:

This is a prospective, multi-center, observational registry to document the baseline, 24-hour and 30-day inflammatory response and procedural outcomes out to 12 month follow-up after femoropopliteal angioplasty or atherectomy-based revascularization procedures.

  1. To observe the femoropopliteal revascularization outcomes post-angioplasty and/or atherectomy and to observe potential correlation between patency outcomes and the levels of MCP-1, C-reactive protein and MMP-9 from baseline to 24 hours and 30 days post-procedure.
  2. To provide a comparator dataset to the investigational DANCE trial, which has the same enrollment criteria as this observational trial but includes the investigational use of a local drug therapy to limit inflammation caused by mechanical revascularization.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 31 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes
Study Start Date : May 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atherectomy

Up to 20 atherectomy procedures at up to 5 sites in the United States. Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure.

This registry will also observe outcomes (target lesion revascularization rates, 6 and 12 month duplex ultrasound-detected binary restenosis with PSVR>2.4) post-atherectomy revascularization procedures.

Device: Atherectomy System
Device: Orbital or Directional or Laser Atherectomy Systems Atherectomy selection is driven by preference of the operator

Angioplasty

Up to 20 angioplasty procedures at up to 5 sites in the United States. Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure.

This registry will also observe outcomes (target lesion revascularization rates, 6 and 12 month duplex ultrasound-detected binary restenosis with PSVR>2.4) post-angioplasty revascularization procedures.

Device: Balloon Angioplasty
Device: Balloon Angioplasty Selection is driven by preference of the operator




Primary Outcome Measures :
  1. Change in inflammatory biomarkers [ Time Frame: Baseline to 24-hours post-procedure and 30-days post-procedure ]
    Change in inflammatory biomarkers (hs-CRP, MCP-1 and MMP-9) from baseline to 24 hours post-procedure and 30-days post-revascularization procedure.


Secondary Outcome Measures :
  1. Target Lesion Revascularization [ Time Frame: 6 and 12 months post-procedure ]
    This registry will prospectively collect data from patients diagnosed with peripheral arterial disease to observe the restenosis rates in peripheral arteries compared with subjects enrolled in the DANCE trial (Mercator MedSystems TSP0149).

  2. Comparing biomarker (hs-CRP, MCP-1 and MMP-9) results [ Time Frame: Baseline to 24 hours post-procedure and 30-days post-revascularization procedure ]
    This registry will prospectively collect data from patients diagnosed with peripheral arterial disease to observe the correlation between the levels of MCP-1, C-reactive protein and MMP-9 after angioplasty or atherectomy procedures in peripheral arteries compared with subjects enrolled in the DANCE trial (Mercator MedSystems TSP0149). Objective measurement of biomarkers will be performed by a contract laboratory to avoid bias.



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
Sampling Method:   Non-Probability Sample
Study Population
Male or female at least 18 years of age presenting with a de novo or nonstented restenotic lesions >90 days from prior angioplasty and/or atherectomy of lesions causing >70% narrowing in the superficial femoral and/or popliteal arteries and totalling up to 15 cm in length (with no greater than 3 cm length of contiguous intervening normal artery), Rutherford Category 2-4, and with a reference vessel diameter of 3 to 8 mm.
Criteria

Inclusion Criteria:

Screening Criteria

  • Male or non-pregnant female ≥18 years of age
  • Rutherford Clinical Category 2-4
  • Clinical diagnosis of PAD requiring revascularization, secondary to atherosclerosis affecting a lower limb.
  • Patient is willing to provide informed consent and comply with the required follow up visits Procedural Criteria
  • De novo or nonstented restenotic lesions >90 days from prior angioplasty and/or atherectomy, at least 3 cm from any previously placed stent or vascular surgery site
  • >70% diameter stenosis up to 15 cm in total length (with no greater than 3 cm length of contiguous intervening normal artery) in the superficial femoral and/or popliteal artery (between the profunda and tibioperoneal trunk)
  • Reference vessel diameter ≥3mm and ≤ 8mm
  • Successful wire crossing of lesion
  • A patent artery proximal to the index lesion free from significant stenosis (significant stenosis is defined as >50% in iliac or >30% stenosis in common femoral artery) as confirmed by angiography (treatment of target lesion after successful treatment of iliac or common femoral artery lesions is acceptable)

Exclusion Criteria:

Screening Criteria

  • Pregnant, nursing or planning on becoming pregnant in < 2years
  • Life expectancy of <2 years
  • Known active malignancy
  • History of solid organ transplantation
  • Patient actively participating in another investigational device or drug study
  • History of hemorrhagic stroke within 3 months
  • Previous or planned surgical or interventional procedure within 30 days of index procedure
  • Chronic renal insufficiency with eGFR <29
  • Prior bypass surgery, drug-coated balloon or stenting of the target lesion
  • Contra-indication or known hypersensitivity to contrast media or physician prescribed antiplatelet regimen as applicable
  • Systemic fungal infection
  • Anticipated use of IIb/IIIa inhibitor prior to index lesion treatment
  • Acute or sub-acute thrombus, acute vessel occlusion or sudden symptom onset
  • Acute limb ischemia
  • Inability to ambulate (e.g. from prior ipsilateral or contralateral amputation)
  • Patient is receiving steroids already, however locally acting inhaled steroids for asthma treatment do not exclude patients from the trial Procedural Criteria
  • Lesions extending into the trifurcation or above the profunda
  • Heavy eccentric or moderate circumferential calcification at index lesion
  • Lesion length is >15 cm as measured from proximal normal vessel to distal normal vessel, or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
  • Inadequate distal outflow defined as absence of at least one patent tibial artery (no lesion >50% stenosis) with flow into the foot
  • Use of adjunctive therapies other than angioplasty, atherectomy (mechanical or laser) or bare metal stenting (i.e. scoring/cutting balloon, drug-eluting stent, drug-coated balloon, cryoplasty, etc.)

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): NCT02469532


Locations
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United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, Louisiana
Endovascular Technologies (Willis Knighton Medical Center)
Bossier City, Louisiana, United States, 7111
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, North Carolina
Rex Hospital
Raleigh, North Carolina, United States
United States, Texas
Mission Research Institute
New Braunfels, Texas, United States, 78130
Palestine Regional Medical Center
Palestine, Texas, United States, 75801
Sponsors and Collaborators
Mercator MedSystems, Inc.
Investigators
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Principal Investigator: Jason A Yoho, MD Mission Research, New Braunfels, TX
Additional Information:

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Responsible Party: Mercator MedSystems, Inc.
ClinicalTrials.gov Identifier: NCT02469532    
Other Study ID Numbers: CIP0181
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases