Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

Peripheral Arterial Diseases Clinical Trial

— DANCE  

Official title:

Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983449
• Other study ID #: TSP0149
• Secondary ID: 1142183
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2013
• Last updated: March 6, 2018
• Start date: November 2013
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Mercator MedSystems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries.

Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel treatment length.

Description:

This trial will examine the ability for adventitial dexamethasone to safely delay restenosis in patients at least 18 years of age, who have peripheral atherosclerotic lesions involving the superficial femoral and/or popliteal arteries. These patients have no current therapeutic alternatives beyond the procedure used to open, or revascularize, their superficial femoral and/or popliteal arteries. Metal stents have the potential to fracture when implanted in this artery segment due to continual flexion and bending of the knee. It is desirable to improve the patency of this artery after percutaneous transluminal angioplasty (PTA) and/or atherectomy-based revascularization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: January 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, testing schedule, and medication regimen

• 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 < 2 years

• 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, stenting of the target lesion

• Inability to take required study medications

• Contra-indication or known hypersensitivity to dexamethasone sodium phosphate, contrast media, or Physician prescribed antiplatelet regimen as indicated

• 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

• Prior participation of the index limb in the current study (contralateral treatment is allowed)

• 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, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Catheter needle through the vessel wall

• 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.)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Diseases
• Peripheral Vascular Diseases

Intervention

Drug:
• Dexamethasone Sodium Phosphate Injection, USP
Adventitial infusion of dexamethasone after angioplasty or atherectomy-based revascularization of the superficial femoral or popliteal artery.

Locations

Country	Name	City	State
United States	Albany Vascular Group	Albany	New York
United States	Cardiovascular Medical Group of Southern California / Cardiovascular Research Foundation	Beverly Hills	California
United States	Deborah Heart & Lung Center	Browns Mills	New Jersey
United States	OhioHealth	Columbus	Ohio
United States	DFW Vascular Group	Dallas	Texas
United States	VA Eastern Colorado Healthcare System	Denver	Colorado
United States	St. John Providence Hospital and Medical Center	Detroit	Michigan
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	St. Joseph Hospital	Fort Wayne	Indiana
United States	Plaza Medical Center at Fort Worth	Fort Worth	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Wellmont CVA Heart Institute	Kingsport	Tennessee
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Columbia University Medical Center	New York	New York
United States	Gotham Cardiovascular Research / New York Cardiovascular Associates	New York	New York
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	Munroe Regional Medical Center	Ocala	Florida
United States	St. Joseph Hospital of Orange Heart and Vascular Center	Orange	California
United States	Palestine Regional Medical Center	Palestine	Texas
United States	Coastal Vascular & Interventional	Pensacola	Florida
United States	Arizona Heart Hospital / Abrazo Health Care Research / Tenet Health	Phoenix	Arizona
United States	UPMC Heart & Vascular Institute	Pittsburgh	Pennsylvania
United States	The Miriam Hospital	Providence	Rhode Island
United States	UNC Health Care - Rex Hospital	Raleigh	North Carolina
United States	St.Louis University Hospital	Saint Louis	Missouri
United States	Alpine Research / Utah Cardiology	Salt Lake City	Utah
United States	San Francisco VA Medical Center	San Francisco	California
United States	University of California San Francisco Medical Center	San Francisco	California
United States	University of Washington Veterans Center	Seattle	Washington
United States	Mission Research Institute (Guadalupe Regional Medical Center)	Seguin	Texas
United States	Willis-Knighton Medical Center	Shreveport	Louisiana
United States	Pima Vascular	Tucson	Arizona
United States	MedStar Health Washington Hospital Center	Washington	District of Columbia
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mercator MedSystems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MALE-POD	Acute safety safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of Major Adverse Limb Events or Peri-Operative Death (MALE+POD) within 30 days from the procedure for all subjects.	30 days
Primary	Duplex ultrasound index lesion binary restenosis	Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.	6 months
Primary	Duplex ultrasound index lesion binary restenosis	Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.	12 months
Secondary	Long term safety	Long term safety outcomes that occur after 30 days through 6 months post-procedure will be determined by evaluating adverse events.	30 days to 6 months
Secondary	Duplex ultrasound index lesion flow limiting restenosis	Flow limiting restenosis will be judged by core laboratory as PSVR>4.0.	6 and 12 months
Secondary	Change in inflammatory biomarkers	Change in inflammatory biomarkers will be measured with a panel of biomarkers in 1/3 of patients.	Baseline and 24 hours
Secondary	Vascular patency	Target lesion revascularization (TLR) rate, target extremity revascularization (TER) rate, limb salvage rate and primary patency (PSVR=2.4 and no TLR) at 6, 12, 18 and 24 months. Note: provisional stenting performed during the index procedure shall not be considered to be TLR, TER or loss of primary patency.	6, 12, 18 and 24 months
Secondary	Clinical outcome measures	Modified Walking Impairment Questionnaire, Ankle-Brachial Index, Rutherford Score.	1, 6, 12, 18 and 24 months
Secondary	Infusion Technical Success	Distribution grade around infusion sites.	Intraprocedural
Secondary	Procedural Success	Establishment of antegrade flow with residual stenosis of <30% by angiogram.	Intraprocedural
Secondary	Healthcare Economics	Number of return visits and hospitalizations, time from index procedure to required revascularization and number of index-lesion-related readmissions within 30 days will be measured.	30 days