A Phase 1/2 interventional study of PTCA and paclitaxel coated balloon catheter (device with drug) in Coronary Restenosis, sponsored by University Hospital, Saarland. Completed at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by University Hospital, Saarland · Phase 1/2, Interventional, and Treatment
The PACCOCATH ISR study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.
Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR.
Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=52 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, \< 25 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.
97 studies on the registry are indexed under Coronary Restenosis; 9 are open to participants now.
This study's enrollment of 52 is below the median of 240 across 59 interventional studies indexed under Coronary Restenosis.
Browse Coronary Restenosis studies →University Hospital, Saarland is the lead sponsor of 41 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PTCA of ISR
Device: PTCA
DCB PTCA of ISR
Combination Product: paclitaxel coated balloon catheter (device with drug)
angiographic late lumen loss
angiographic late lumen loss
Time frame: 6 months
binary restenosis rate
binary restenosis rate
Time frame: 6 months
major adverse cardiac events
major adverse cardiac events
Time frame: 12 months
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Saarland