Clinical Trials Logo

Clinical Trial Summary

Treatment of patients with drug-eluting stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from drug-eluting stent restenosis.


Clinical Trial Description

Treatment of patients with drug-eluting stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with drug-eluting stent restenosis.

This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with drug-eluting stent restenosis. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01239940
Study type Interventional
Source Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Contact
Status Recruiting
Phase Phase 4
Start date January 2010

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 NCT04647253 - A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) Phase 3
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
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