A. Database searches
Database: Ovid MEDLINE(R) <1946 to June Week 3 2015>
1 ClearWay.mp. (23)
2 Cardiovascular Diseases/ or cardiovascular.mp. (368885)
3 catheter.mp. or Catheters/ (111731)
4 2 and 3 (3496)
5 limit 4 to (humans and yr="2005 -Current" and "therapy (maximizes specificity)") (83)
6 1 or 5 (106)
Database: Embase <1974 to 2015 30 June>
1 peripheral infusion catheter/ (33)
2 ClearWay.mp. (70)
3 1 or 2 (93)
Database: Cochrane Library to 30 June 2015
1 ClearWay (9)
B. Reference lists of reviews and other identified studies were checked to identify any further studies.
C. Information provided by the manufacturer for supporting this briefing report was also checked to identify any further studies.
D. The internet. Google Search: 30 June
Search Terms: ClearWay RX, Crystal AMI, Coctail, Libra AND coronary.
E. ClinicalTrials.gov, WHO ICTRP, and Current Controlled Trials were also searched for ongoing trials.
F. The manufacturer's website was thoroughly investigated.
The inclusion criteria were as follows:
Patients: adults with diffuse and multi-segment cardiovascular disease, particularly coronary artery. Patients with a thrombus occluding or narrowing an artery that needs to be cleared. Presentation could be STEMI or NSTEMI, vein grafts, no-reflow or slow flow, complex femoral popliteal occlusions, cases of critical limb ischaemia.
Intervention: therapeutic drug delivery through the ClearWay RX balloon catheter. Drugs used include glycoprotein (GP) IIb/IIIa inhibitors (mostly) but also nitroglycerin, sodium nitroprusside, tPA, retevase, and paclitaxel.
Comparator(s): drug delivery of the same drug using a sheath or guide catheter in the same artery, or injection of the same drug via a peripheral vein.
Outcomes: any clinical, safety and resource use outcomes, such as removal of thrombus, restoration of blood flow, damage to artery wall, CVA, PE, thrombus relocation causing infarction.
Study design: any controlled clinical studies including observational studies.