AGENT IDE

What is the Purpose of this Study?

To assess the safety and effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.


Eligibility

  • Subject must be at least 18 years of age
  • Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed
  • Subject is eligible for percutaneous coronary intervention (PCI)
  • Subject is willing to comply with all protocol-required follow-up evaluation
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Prospective, Randomized , Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis

Study Details
Disease Type/Condition

Other

Principal Investigator

Dohad, Suhail

Age Group

Adult

Phase

Not Available

IRB Number

STUDY00001213

ClinicalTrials.gov ID

NCT04647253

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Details
Disease Type/Condition

Other

Principal Investigator

Dohad, Suhail

Age Group

Adult

Phase

Not Available

IRB Number

S2358

ClinicalTrials.gov ID

NCT04647253

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org