Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon

Peripheral Arterial Disease Clinical Trial

— PREVEIL  

Official title:

A Prospective, Multi-Center, Single-Arm Trial to Assess the Safety and Feasibility of the SurModics Drug Coated Balloon in the Treatment of Subjects With De Novo Lesions of the Femoropopliteal Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648620
• Other study ID #: SUR15-001
• Status: Completed
• Phase: N/A
• Start date: April 5, 2016
• Est. completion date: February 11, 2020

Study information

• Verified date: July 2022
• Source: SurModics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and popliteal arteries. The trial will enroll up to 15 subjects.

Description:

PREVEIL will enroll patients presenting with angiographic evidence of significant stenosis in the femoral or popliteal arteries. All enrolled subjects will be treated with the SurVeil DCB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 11, 2020
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must meet all of the following criteria to participate in the trial:

• Subject is = 18 years.
• Subject has lifestyle-limiting claudication or rest pain with Rutherford classification 2, 3 or 4.
• Subject has provided written informed consent.
• Subject is willing to comply with study follow-up requirements.
• A de novo target lesion in the femoral or popliteal arteries.
• Target lesion must have angiographic evidence of = 50% stenosis by operator visual estimate.
• Target lesion must be = 90 mm in length (one long lesion or multiple serial lesions) by operator visual estimate. Note: Multiple serial lesions are allowed provided that they can be treated as a single lesion with one balloon.
• Target vessel must have an reference vessel diameter (RVD) of 4 mm to 6 mm by operator visual estimate.
• After pre-dilatation, the target lesion is = 70% residual stenosis, absence of a flow limiting dissection and treatable with a single balloon (lesion length =90 mm, limited to 100-mm balloon in EFS).
• A patent inflow artery free from significant stenosis (= 50% stenosis) as confirmed by angiography.
• At least one patent native outflow artery to the ankle or foot, free from significant stenosis (= 50% stenosis) as confirmed by angiography. Exclusion Criteria:

Subjects will be excluded from the trial if any of the following criteria are met:

• Subject has acute limb ischemia.
• Subject has Rutherford classification of 0, 1, 5 or 6.
• Subject previously underwent any lower extremity percutaneous transluminal angioplasty (PTA) using a DCB within 3 months.
• Subject has had prior vascular intervention within 2 weeks before the planned study index procedure or subject has planned vascular intervention within 30 days after the study index procedure.
• Subject is pregnant and/or breast-feeding or intends to become pregnant during the time of the study OR subject is a male intending to father children within 60 days of index procedure.
• Life expectancy less than 2 years.
• Subject has a known allergy to contrast medium that cannot be adequately pre-medicated.
• Subject is allergic to ALL antiplatelet treatments.
• Subject has impaired renal function (i.e. serum creatinine level = 2.5 mg/dl).
• Subject is dialysis dependent.
• Subject is receiving immunosuppressant therapy.
• Subject has known or suspected active infection at the time of the index procedure.
• Subject has platelet count < 100,000/mm3 or > 700,000/mm3.
• Subject has white blood cell (WBC) count < 3,000/mm3.
• Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the index procedure.
• Subject is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT).
• Subject is unable to tolerate blood transfusions because of religious beliefs or other reasons.
• Subject is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
• Subject is known to be incarcerated, mentally incompetent and/or an alcohol or drug abuser.
• Subject is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or subject is planning to participate in such studies prior to the completion of this study.
• Subject has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or has planned surgical or interventional procedures within 30 days of entry into this study.
• Previous intervention at the lesion site including previous stenting within 3 cm of the target lesion or previous bypass surgery of the target lesion.
• Previous treatment of the target vessel with thrombolysis or surgery.
• Severe concentric calcification of the target lesion.
• Target lesion involves an aneurysm or is adjacent to an aneurysm.
• Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy or re-entry devices.
• Significant vessel tortuosity or other parameters prohibiting access to the target lesion.
• Presence of thrombus in the target vessel.
• Iliac inflow disease requiring treatment , unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as = 30% residual diameter stenosis without death or major complications.
• Absence of at least one patent native outflow artery.
• Presence of an aortic, iliac or femoral artificial graft.
• Failure to cross the target lesion with a guide wire. Successful crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation.
• Failure to successfully pre-dilate the target lesion. Successful pre-dilatation is defined as residual stenosis = 70% with no flow-limiting dissection.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• SurVeil Drug Coated Balloon
Angioplasty procedure with the SurModics SurVeil Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Paclitaxel-coated PTA Catheter)

Procedure:
• Angioplasty
Angioplasty procedure with the SurModics SurVeil Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Paclitaxel-coated PTA Catheter)

Locations

Country	Name	City	State
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Wellmont Health System	Kingsport	Tennessee
United States	NC Heart and Vascular Research	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
SurModics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak paclitaxel plasma concentration	Paclitaxel plasma levels will be assessed at baseline, immediately post-index procedure, at 1h, 2h, 4h, 12h (or upon discharge), and 30 days post-index procedure.	Up to 30 days
Secondary	Area under the drug concentration time curve	Area under the drug concentration time curve from the time of intervention to the time where the paclitaxel level is no longer quantifiable will be measured. Paclitaxel plasma levels will be assessed at baseline, immediately post-index procedure, at 1h, 2h, 4h, 12h(or upon discharge), and 30 days post-index procedure.	Up to 30 days
Secondary	Technical success	Technical success, defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device.	At procedure
Secondary	Device success	Device success, defined as achievement of < 50% residual stenosis of the target lesion (by core lab assessed quantitative angiography (QA)) using only the study device.	At procedure
Secondary	Procedure success	Procedure success, defined as achievement of < 50% residual stenosis of the target lesion (by core lab assessed QA) using the study device with or without the use of additional devices, without the occurrence of death, amputation or repeat revascularization of the target vessel during index hospital stay.	At procedure up to 12 hours
Secondary	Resting ankle brachial index		within 90 days of index procedure, and at 6, 12, 24 and 36 months post-index procedure
Secondary	Change in Rutherford classification		baseline, 30 days, 6, 12, 24, and 36 months
Secondary	Change in 6-minute walk test		baseline, 30 days, 6, 12, 24, and 36 months
Secondary	Primary patency	defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis. Restenosis is defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) = 2.5 (core lab assessed) or by = 50% stenosis by QA (core lab assessed)	6 months
Secondary	Continuous DUS Peak systolic velocity ratio (PSVR) as measured by Duplex ultrasound		30 days, 6, 12, 24, and 36 months
Secondary	Late lumen loss	Defined as the difference in minimum luminal diameter of the target lesion between the index intervention and 6-month angiographic follow-up.	baseline, 6 months
Secondary	Quality of life	Assessed by Change in walking Impairment Questionnaire (WIQ) scores	baseline, 30 days, 6, 12, 24, and 36 months
Secondary	Evidence of Paclitaxel toxicity	Evidence of paclitaxel toxicity (rash, myelosuppression on blood counts, hepatitis, neuromuscular changes, hypotension, electrocardiogram (ECG) abnormalities, or gastrointestinal upset).	At hospital discharge, 30 days
Secondary	Major vascular complications		At hospital discharge, 30 days
Secondary	Thrombolysis in Myocardial Infarction (TIMI)-defined major and minor bleeding		At hospital discharge, 30 days
Secondary	Major adverse events	defined as a composite of death, index limb amputation and TLR	30 days, 6, 12, 24, and 36 months
Secondary	All-cause death		30 days, 6, 12, 24, and 36 months
Secondary	Index limb above the ankle amputation		30 days, 6, 12, 24, and 36 months
Secondary	Index limb below the ankle amputation		30 days, 6, 12, 24, and 36 months
Secondary	Clinically-driven TLR		30 days, 6, 12, 24, and 36 months
Secondary	Clinically-driven target vessel revascularization (TVR)		30 days, 6, 12, 24, and 36 months
Secondary	Arterial thrombosis of the treated segment on angiography		30 days, 6, 12, 24, and 36 months
Secondary	Embolic events of the index limb		30 days, 6, 12, 24, and 36 months