Subjects receiving Absorb BVS

The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating].

Achievement of a final in-scaffold residual diameter stenosis of < 50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device is considered to have failed if it did not meet the requirements of the definition for clinical device success.

Achievement of a final in-scaffold diameter stenosis of < 50% by online QCA or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.

Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)

Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)

all TLR

• Access site (femoral, brachial, radial)

• Lesion preparation (Lesion 1, 2, 3, etc.)

  • Balloon pre-dilatation (yes - Max balloon size/Max balloon pressure, Cutting balloon yes/no, Other yes/no)
  • Techniques used to adequately prepare the lesion (de-calcification techniques (Rotablator yes/no, Other yes/no))

• Treatment parameters

  • CASS numbers
  • No. of scaffolds per analyzable lesion (Lesion 1, 2, 3, etc.)
  • Scaffold length (Lesion 1, Lesion 2, Lesion 3, etc.)
  • Lesion length (Lesion 1, Lesion 2, Lesion 3, etc.)
  • Bailout / bailout device (if bailout required)

• Post-treatment of lesion?

  • Balloon post-dilatation (no, yes - Max balloon diameter/Max balloon pressures/balloon length)
  • Jailed side-branch (no, yes). If yes, treatment of jailed sidebranch? (no, yes)