Coronary Restenosis
Conditions
Keywords
in stent restenosis, paclitaxel coated balloon catheter, paccocath, drug eluting balloon
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPTCA
COMBINATION_PRODUCTpaclitaxel coated balloon catheter (device with drug)
Sponsors
University Hospital, Saarland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Clinical evidence of stable or unstable angina or a positive functional study * Single, restenotic lesion in a stented coronary artery (allowed are multiple lesions but only the target lesion is amenable for percutaneous intervention, i.e. no 'staged' procedures involving non-target lesions) * Diameter stenosis \> 70% (visual estimate) * Stented segment length \< 25 mm * Vessel diameter =\> 2.5 mm * Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization * Signed patient informed consent form * Patients and treating physicians agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol
Exclusion criteria
* Left ventricular ejection fraction of \< 30% * Target lesion/vessel with any of the following characteristics: Clear angiographic calcification in the target lesion or greater than mild calcification in the proximal vessel (minimally radiopaque densities that are discrete and non-linear). Visible thrombus proximal to the lesion. * Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated. * Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy causing the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years). * Severe chronic renal insufficiency. * Significant gastrointestinal (GI) bleed within the past six months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions. * Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and/or requires additional anti-platelet and/or anti-coagulation treatment. * Participating in another device or drug study within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| angiographic late lumen loss | 6 months | angiographic late lumen loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| binary restenosis rate | 6 months | binary restenosis rate |
| major adverse cardiac events | 12 months | major adverse cardiac events |
Countries
Germany
Outcome results
None listed