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

NCT02648620 | Completed

• 1 other identifier: SUR15-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Keywords

Paclitaxel; Percutaneous Transluminal Angioplasty; PAD; Peripheral Artery Disease; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Area under the drug concentration time curve

  Up to 30 days

• Technical success

  At procedure

• Device success

  At procedure

• Procedure success

  At procedure up to 12 hours

• Resting ankle brachial index

  within 90 days of index procedure, and at 6, 12, 24 and 36 months post-index procedure

Study Arms (1)

SurVeil Drug Coated Balloon catheter

EXPERIMENTAL

Paclitaxel Coated Balloon catheter for angioplasty

Device: SurVeil Drug Coated Balloon; Procedure: Angioplasty

Interventions

SurVeil Drug Coated Balloon DEVICE

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

Also known as: SurModics SurVeil

SurVeil Drug Coated Balloon catheter

Angioplasty PROCEDURE

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

Also known as: SurModics SurVeil

SurVeil Drug Coated Balloon catheter

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SurModics, Inc.: lead

Study Sites (3)

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Wellmont Health System

Kingsport, Tennessee, 37660, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christopher Metzger, MD, FACC, FSCAI

  Wellmont CVA Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: January 7, 2016
• Study Start: April 5, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 11, 2020
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

US (3)