Clinical Trials Logo
  1. Home
  2. In-Stent Restenosis
  3. NCT04647253

A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) — AGENT IDE  

In-Stent Restenosis Clinical Trial

Official title:
AGENT IDE: A Prospective, Randomized (2:1), 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 (ISR)

Clinical Trial Summary

AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04647253
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 11, 2021
Completion date September 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT00341562 - Genomics of In-Stent Restenosis N/A
Completed NCT05509296 - Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease N/A
Not yet recruiting NCT06090890 - Anti-inflammatory Therapy for Recurrent In-stent Restenosis Phase 4
Active, not recruiting NCT00998439 - Treatment of Drug-eluting Stent (DES) In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Phase 2
Active, not recruiting NCT05731700 - CVT-ISR First in Human Trial for Coronary In-Stent Restenosis N/A
Completed NCT03260517 - The PREVAIL Study N/A
Not yet recruiting NCT03588962 - Metal Allergy In-Stent Restenosis Study N/A
Completed NCT00393315 - P E P C A D II, The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat In-Stent Restenoses Phase 2
Recruiting NCT03874481 - The Effect of Sleep Quality on Coronary Artery Disease and In Stent Restenosis
Active, not recruiting NCT01127958 - DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent. N/A
Active, not recruiting NCT03529006 - Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis N/A
Completed NCT00485030 - Diffuse Type In-Stent Restenosis After Drug-Eluting Stent Phase 4
Not yet recruiting NCT03809754 - Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis N/A
Completed NCT00916279 - PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis Phase 1/Phase 2
Recruiting NCT05473884 - Lesion Preparation in Femoropopliteal Artery Occlusion Disease
Recruiting NCT01239940 - RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent) Phase 4
Active, not recruiting NCT01239953 - RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent) Phase 4
Not yet recruiting NCT06148441 - Role of Novel Biomarkers Associated With In-stent Restenosis After Percutaneous Coronary Intervention
Completed NCT05512832 - In-stent Restenosis and Pericoronary Fat Attenuation Index
Recruiting NCT03521843 - LDD in Treatment of Femoropopliteal ISR N/A