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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Atherectomy System; Device: Balloon Angioplasty

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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • Louisiana
    • Bossier City, Louisiana, United States, 7111
      • Endovascular Technologies (Willis Knighton Medical Center)
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • North Carolina
    • Raleigh, North Carolina, United States
      • Rex Hospital
  • Texas
    • New Braunfels, Texas, United States, 78130
      • Mission Research Institute
    • Palestine, Texas, United States, 75801
      • Palestine Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Revascularization	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).	6 and 12 months post-procedure
Comparing biomarker (hs-CRP, MCP-1 and MMP-9) results	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.	Baseline to 24 hours post-procedure and 30-days post-revascularization procedure

Collaborators and Investigators

• Sponsor: Mercator MedSystems, Inc.
• Investigators: Principal Investigator: Jason A Yoho, MD, Mission Research, New Braunfels, TX

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: May 14, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: CIP0181