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

NCT02469532 | Completed

• 1 other identifier: CIP0181
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 6

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Target Lesion Revascularization

  6 and 12 months post-procedure

• Comparing biomarker (hs-CRP, MCP-1 and MMP-9) results

  Baseline to 24 hours post-procedure and 30-days post-revascularization procedure

Study Arms (2)

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

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

Interventions

Balloon Angioplasty DEVICE

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

Angioplasty

Atherectomy System DEVICE

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

Atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercator MedSystems, Inc.: lead

Study Sites (6)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Endovascular Technologies (Willis Knighton Medical Center)

Bossier City, Louisiana, 7111, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Rex Hospital

Raleigh, North Carolina, United States

Location

Mission Research Institute

New Braunfels, Texas, 78130, United States

Location

Palestine Regional Medical Center

Palestine, Texas, 75801, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jason A Yoho, MD

  Mission Research, New Braunfels, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: June 11, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

US (6)