NCT01915420 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Basavarajaiah S, Naganuma T, Latib A, Colombo A
Can bioabsorbable scaffolds be used in calcified lesions? Catheter Cardiovasc Interv. 2014 Jul 1;84(1):48-52. doi: 10.1002/ccd.24939. Epub 2013 Aug 31.
Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW
Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.
Patel N, Banning AP
Bioabsorbable scaffolds for the treatment of obstructive coronary artery disease: the next revolution in coronary intervention? Heart. 2013 Sep;99(17):1236-43. doi: 10.1136/heartjnl-2012-303346. Epub 2013 Mar 8. Review.
Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA
Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.

Postmarketing Surveillance Registry to Monitor Everolimus-eluting Bioresorbable Vascular Scaffold Following Rotational Atherectomy for the Treatment of Complex Coronary Lesions - The ASSURE ROT Registry

Details for clinical trial NCT01915420

Clinical trial NCT01915420 - References