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

Coronary Restenosis Clinical Trial

— ISAR-DESIRE 3A  

Official title:

Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue Drug-eluting Coronary Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367495
• Other study ID #: GE IDE No.S03814
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 25, 2017

Study information

• Verified date: January 2019
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• PCB
PCB with Citrate-based excipient

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment percent diameter stenosis (%DS)		at 6-8 months
Secondary	In-segment minimal lumen diameter and binary restenosis		at 6-8 months
Secondary	Composite of death or myocardial infarction		at 12 months
Secondary	Target lesion revascularization and thrombosis		at 12 months