ADVANCEd NanoTherapies SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter to Treat Coronary In-stent Restenosis (ISR) and de Novo Lesions

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions \<3.00 mm in diameter in patients with symptomatic coronary artery disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years or minimum legal age as required by local regulations.

• Documented stable or unstable angina, positive functional test, or non -ST elevation myocardial infarction which, in the judgment of the operator, is attributable to disease in coronary vessel or in-stent restenosis, and the patient is deemed an appropriate candidate for PCI in accordance with the applicable guidelines on percutaneous coronary intervention.

• Note: participants with NSTEMI must have enzymes that are trending down or are within normal limits prior to enrollment.

• Life expectancy \>1 year in the Investigator's opinion.

• Participant is willing and able to cooperate with study procedures and follow-up evaluations.

• Treatment of only one target lesion required

‣ Tandem lesions treated by a single DCB will be considered one target lesion.

⁃ Up to one de novo lesion in a separate vessel may be treated per standard of care at the procedure. Non-target lesions must be successfully treated under the same criteria of the target lesion, before treating the target lesion.

• Target lesion must be ≤36 mm in length.

• Target lesion must have a stenosis ≥ 50% and \< 100%.

• Target lesion must have a visually estimated reference vessel diameter of:

‣ ISR lesions: 2.0 to 4.0 mm in diameter (inclusive)

⁃ de novo lesions: 2.0 to \<3.0 mm in diameter

• ISR lesions only: target lesion must be within a previous BMS or DES that does not extend \>5.0 mm beyond the proximal or distal edge.

Locations
Other Locations
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Contact Information
Primary
Marwan Berrada-Sounni
mberrada@advnanot.com
(415) 517-0867
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2029-01
Participants
Target number of participants: 30
Treatments
Experimental: SirPlux Duo™ Dual API-Coated PTCA Balloon Catheter
Subject who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with SirPlux DUO PTCA
Sponsors
Leads: Advanced NanoTherapies

This content was sourced from clinicaltrials.gov