Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES

Not Applicable

Completed

• Conditions: Coronary Restenosis
• Interventions: Device: PCB

• Registration Number: NCT02367495
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

Hypothesis:

Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES)

Detailed Description

The optimal management of patients presenting with drug-eluting stent (DES) restenosis remains unclear. Data from recent randomized clinical trials have suggested that angioplasty with drug-coated balloons (DCB) is associated with excellent clinical outcomes. However, as the effectiveness of DCB devices depends critically on the specific composition of its matrix coating there may be important differences in clinical performance between different DCB devices. The prospective, non-randomized, single arm, historical-control ISAR-DESIRE 3A trial is designed to test that hypothesis that angioplasty with a novel paclitaxel-coated balloon with citrate-based excipient (Agent PCB, Boston Scientific) will be non-inferior to a conventional paclitaxel-coated balloon with iopromide excipient (SeQuent Please PCB, B. Braun; data from ISAR-DESIRE 3) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES). The key inclusion criteria are patients with symptoms and/or objective signs of ischemia, restenosis at the site of previous limus-analogue DES implantation and written, informed consent. The primary endpoint is in-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography. Sample size calculation is based on a non-inferiority analysis: %DS of 35% after Both PCB, non-inferiority margin of 7% absolute, 1-sided α-level of 0.05 and power of 80% resulting in 102 patients per group. To account for possible FU losses 125 patients in total will be enrolled.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Primary Completion: 2017-10-25
• Study Completion: 2017-10-25
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

1. Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
2. Written, informed consent by the patient for participation in the study.
3. In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria

1. Age < 18 years
2. Cardiogenic shock
3. Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
4. Target lesion located in the left main trunk or bypass graft.
5. Target lesion located in small vessel (vessel size < 2.0 mm)
6. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
7. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
8. Contraindications to antiplatelet therapy, paclitaxel
9. Pregnancy (present, suspected or planned) or positive pregnancy test.
10. Previous enrollment in this trial.
11. Patient's inability to fully comply with the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCB	PCB	Paclitacel-coated balloon (Agent, Boston Scientific)

Primary Outcome Measures

Name	Time	Method
In-segment percent diameter stenosis (%DS)	at 6-8 months

Secondary Outcome Measures

Name	Time	Method
Target lesion revascularization and thrombosis	at 12 months
Composite of death or myocardial infarction	at 12 months
In-segment minimal lumen diameter and binary restenosis	at 6-8 months

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Bavaria, Germany