Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

Restenosis Clinical Trial

— SFA ISR  

Official title:

A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02063672
• Other study ID #: CL0018-01
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2019
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Male or non-pregnant female =18 years of age

2. Rutherford Clinical Category 2-4

3. Significant (= 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery

4. Lesion measures between 4 and 18 cm

5. Target vessel diameter between =4 and =6 mm and able to be treated with available device size matrix

6. A patent inflow artery free from significant lesion (=50% stenosis) as confirmed by angiography

7. Successful crossing and predilatation of the target lesion with a guidewire

8. At least one patent native outflow artery to the ankle, free from significant (=50%) stenosis as confirmed by angiography that has not previously been (nor planned to be) revascularized

9. No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment

Key Exclusion Criteria:

1. Life expectancy of <1 year

2. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study NOTE: Enrollment in another drug or device clinical trial during the follow up period is not allowed

3. History of stroke within 3 months

4. History of MI, thrombolysis or angina within 2 weeks of enrollment

5. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion

6. Target lesion involves a previously placed covered stent or drug-eluting stent

7. Grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent

8. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication

9. Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion

10. Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)

Related Conditions & MeSH terms

• Femoral Artery Occlusion
• Femoral Artery Stenosis
• Restenosis

Intervention

Device:
• Lutonix DCB

• Standard Uncoated Balloon Angioplasty Catheter
PTA Catheter

Locations

Country	Name	City	State
United States	TriHealth, Inc.	Cincinnati	Ohio
United States	Northwestern University	Evanston	Illinois
United States	Cardiology Associates	Fairhope	Alabama
United States	Hunterdon Cardiovascular Associates	Flemington	New Jersey
United States	University of Texas Medical Branch	Galveston	Texas
United States	Hattiesburg Clinic, PA	Hattiesburg	Mississippi
United States	Jackson Heart Clinic, P.A.	Jackson	Mississippi
United States	Wellmont Cardiology Services, Inc.	Kingsport	Tennessee
United States	Radiology and Imaging Specialists of Lakeland, P.A.	Lakeland	Florida
United States	Mount Sinai Medical Center	Miami	Florida
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	Yale University	New Haven	Connecticut
United States	Kansas City Vascular Foundation	North Kansas City	Missouri
United States	Minneapolis Radiology and Vascular Research Foundation	Plymouth	Minnesota
United States	The Miriam Hospital - A Lifespan Partner	Providence	Rhode Island
United States	Rex Hospital, Inc.	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	William Beaumont Hospital Research Institute	Royal Oak	Michigan
United States	MedStar Health Research Institute	Washington	District of Columbia
United States	Metropolitan Hospital d/b/a Metro Health Hospital	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Primary Patency at 1 Year	Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.	12 Months
Primary	Percentage of Participants Without Primary Safety Events	Primary Safety Events include: All Cause Perioperative (=30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year	12 Months
Secondary	Percentage of Participants With Device Success	Device success is defined as, on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.	During the Index Procedure (90 mins)
Secondary	Percentage of Participants With Technical Success	Technical success of the balloon procedure is defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion and a successful withdrawal of the study system with the achievement of < 30% residual percent stenosis without deployment of a bail-out stent.	During the Index Procedure (90 mins)
Secondary	Percentage of Participants With Procedural Success	Procedural Success is defined as attainment of =30% residual stenosis in the treatment area by independent core lab analysis without major adverse events (defined as occurrence of death, amputation of the target limb, or repeat revascularization of the target lesion) during the index procedure and through the hospital stay.	During the Index Procedure (90 mins)
Secondary	Percentage of Participants With Primary Patency at 6 and 12 Months	Primary Patency is defined as Freedom from CEC-adjudicated Clinically-Driven TLR and from Core laboratory-adjudicated Binary Restenosis. Binary restenosis is based on threshold Doppler peak systolic velocity ratio (PSVR) = 2.5 (together with waveform analysis & color mosaic appearance) or based on angiographic = 50% diameter stenosis (if angiography is performed although not required per protocol).	6 months and 12 months
Secondary	Percentage of Participants With Secondary Patency at 6 Months and 12 Months	Secondary patency is defined as the absence of Binary Restenosis as adjudicated by the blinded, independent core laboratory, independent of whether or not patency is re-established via an endovascular procedure.	6 months and 12 months
Secondary	Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)	Clinically-driven TLR is defined as revascularization of the target vessel with evidence of target vessel diameter stenosis >50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms), OR revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms.	6 months and 12 months
Secondary	Percentage of Participants Without Target Lesion Revascularization (TLR)	TLR is defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.	6 months and 12 months
Secondary	Percentage of Participants With Sustained Clinical Benefit Compared to Baseline	Sustained clinical benefit is defined as an improvement in Rutherford Classification compared to baseline and freedom from target vessel revascularization. The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.	6 months and 12 months
Secondary	Change of Rutherford Classification From Baseline	The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.	6 months and 12 months
Secondary	Change of Resting Ankle Brachial Index (ABI) From Baseline	The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium).	6 months and 12 months
Secondary	Change in Walking Impairment Questionnaire From Baseline	The Walking Impairment Questionnaire (WIQ) is a validated questionnaire that evaluates walking ability with a focus on walking distance, walking speed, and the ability to climb stairs. Participants answer each item on a Likert scale from 0 for "unable to do" to 4 for "no difficulty", and each response is weighted based on the difficulty of the task. The overall score is determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. The overall score ranges from 0-100 with lower scores indicating lower performance.	6 months and 12 months
Secondary	Change in Quality of Life From Baseline	EQ-5D is a standardized tool to assess patient-reported mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, or slight, moderate, severe, or extreme problems. Patients choose the appropriate level in each of the 5 dimensions, which results in a 1-digit number for each dimension. The digits for the 5 dimensions are converted into a single EQ-5D™ index score based on a set of population-based preference weights. For the U.S. general population, possible EQ-5D™ index scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. A downloadable scoring file is available at: https://www.ahrq.gov/rice/EQ5Dscore.htm.; The EQ VAS records a patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). A higher VAS value indicates a higher quality of life.	6 months and 12 Months
Secondary	Percentage of Participants Without Major Vascular Complications (=30 Day)	Freedom from major vascular complications at 30 days follow-up	30 Days
Secondary	Percentage of Participants Without All-Cause Death	Mortality from any cause.	1 month, 6 months, and 12 months
Secondary	Percentage of Participants Without Major Limb Amputation	Major limb amputation is defined as amputation of the lower limb above the ankle.	1 month, 6 months, and 12 months
Secondary	Percentage of Participants Without Minor Limb Amputation	Minor limb amputation is defined as amputation of a part of the foot below the ankle.	1 month, 6 months, and 12 months
Secondary	Percentage of Participants Without Target Vessel Revascularizations (TVR)	A TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel.	1 month, 6 months, and 12 months
Secondary	Percentage of Participants Without Any Target Limb Reinterventions	Any surgical intervention in the target limb.	1 month, 6 months, and 12 months