Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon

NCT04107298 | Completed DMC FDA Device

• 1 other identifier: SUR19-002
• Study Type: interventional
• Target: 35
• Locations: 4 countries
• Sites: 5

Brief Summary

To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.

Conditions

Peripheral Arterial Disease; Critical Lower Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Number of Participants with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death

  MALE is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major amputation is defined as limb amputation above the ankle. Major re-intervention is defined as the creation of new surgical bypass graft, the use of thrombectomy or thrombolysis, or major surgical graft revision such as a jump graft or an interposition graft.

  30 Days

• Primary Efficacy Endpoint: Rate of Late Lumen Loss (LLL)

  LLL is assessed by quantitative vascular angiography (QVA). LLL is the difference between minimum lumen diameter (MLD) immediately after PTA and MLD at 6 months follow-up.

  6 Months

Secondary Outcomes (12)

• Rate of Device Success

  Acute/Periprocedural

• Rate of Technical Success

  Acute/Periprocedural

• Rate of Procedure Success

  Acute/Periprocedural

• Rate of Restenosis

  6 Months or prior

• Number of Participants with Primary Patency

  30 Days, 6 Months, 12 Months, 24 Months

Study Arms (1)

SUNDANCE™ Drug Coated Balloon

EXPERIMENTAL

SUNDANCE™ Drug Coated Balloon

Device: SUNDANCE™ Drug Coated Balloon

Interventions

SUNDANCE™ Drug Coated Balloon DEVICE

Angioplasty procedure with a sirolimus-coated, percutaneous transluminal angioplasty (PTA) balloon catheter

SUNDANCE™ Drug Coated Balloon

Eligibility Criteria

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

You may qualify if:

• Subject is ≥18 years.
• Subject has target limb Rutherford classification 4 or 5. Rutherford classification 3 subjects may be enrolled but will be capped to a limit of 20% of the total enrollment (i.e., no more than 7 Rutherford class 3 subjects may be enrolled in the study).
• Subject has provided written informed consent and is willing to comply with study follow-up requirements.

You may not qualify if:

• Subject has acute limb ischemia.
• Subject underwent intervention involving the target vessel (not a proximal inflow vessel) within the previous 90 days.
• Subject previously underwent PTA of the target lesion vessel using a DCB or DES.
• Subject has had prior vascular intervention in the contralateral limb within 14 days before the planned study index procedure or subject has planned vascular intervention in the contralateral limb within 30 days after the index procedure.
• Subjects with heel gangrene, deep heel ulcers, osteomyelitis of tarsal or metatarsal bones (which extends beyond the metatarsal head immediately adjacent to the metatarso-phalangeal joint), and subjects with exposed vital structures (e.g., medial or lateral malleolus).
• Subjects requiring pedal angioplasty.
• Subjects that are non-ambulatory and confined to bed.
• Women who are pregnant, breast-feeding or intend to become pregnant or men who intend to father children during the time of the study.
• Subject has history of Class 3 (and above) congestive heart failure (CHF) in past 6 months.
• Subject has life expectancy less than 12 months.
• Subject has a known allergy to contrast medium that cannot be adequately pre-medicated.
• Subject has known hypersensitivity to sirolimus
• Subject has a known contraindication to the intended concomitant medications.
• Subject is allergic to ALL antiplatelet treatments.
• Subject has impaired renal function (i.e. serum creatinine level ≥2.5 mg/dL or ≥221 µmol/L).

Sponsors & Collaborators

• SurModics, Inc.: lead

Study Sites (8)

Royal Perth Hospital

Perth, Australia

Location

Prince of Wales Private Hospital

Randwick, Australia

Location

Royal North Shore Hospital

St Leonards, Australia

Location

Universitäts Klinikum Graz

Graz, Austria

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, Germany

Location

MEDINOS Kliniken des Landkreises Sonneberg GmbH

Sonneberg, Germany

Location

Paul Stradins University Hospital

Riga, Latvia

Location

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

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: September 24, 2019
• First Posted: September 27, 2019
• Study Start: June 29, 2020
• Primary Completion: August 23, 2021
• Study Completion: January 30, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

NZ (1); LA (1); AU (1); DE (2)