Clinical Trial: Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis A Prospective, Multi-centre, Non-randomized Clinical Trial With Follow-up Investigations at 1, 6 and 12 Months

Brief Summary: The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.

Detailed Summary:

All patients are treated with the paclitaxel releasing balloon Pantera Lux. The indication is in-stent restenosis in either bare metal stent (BMS) or drug eluting stent (DES).

Clinical follow up visits at 1, 6 and 12 months. Angiographic follow up visit at 6 months.

Sponsor: Biotronik AG

Current Primary Outcome: In-stent Late Lumen Loss [ Time Frame: 6 months ]

Original Primary Outcome: Late Lumen Loss (in-stent) [ Time Frame: 6 months ]

Current Secondary Outcome:

• In-segment Late Lumen Loss [ Time Frame: 6 months ]

  In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.

  Late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA).

  Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).

• Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization) [ Time Frame: 6 months ]

  All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.

  Major Adverse Cardiac Events = MACE Myocardial Infarction = MI Target Lesion Revascularization = TLR Target Vessel Revascularization = TVR

• Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR) [ Time Frame: 12 months ]
  All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee.
• In-stent Diameter Stenosis (%DS) [ Time Frame: 6 months ]

  In-stent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.

  Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.

  Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).

• In-segment Diameter Stenosis (%DS) [ Time Frame: 6 months ]

  In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.

  Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.

  Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).

• Binary In-stent Restenosis [ Time Frame: 6 months ]

  In-sent is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon.

  Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).

  Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.

  Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).

• Binary In-segment Restenosis [ Time Frame: 6 months ]

  In-segment is defined as from proximal shoulder to distal shoulder of the dilated Pantera Lux balloon plus 5 mm proximal and 5 mm distal.

  Binary restenosis was defined as a ≥ 50% diameter stenosis at follow-up as evaluated by offline quantitative coronary angiography (QCA).

  Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.

  Offline quantitative coronary angiography (QCA) analysis was performed by an independent core laboratory (Ulrich Dietz, MD, Deutsche Klinik für Diagnostik, Wiesbaden, Germany).

• Technical Success [ Time Frame: directly after intervention (after finalized treatment) ]

  Technical success is defined as successful vascular access, completion of the endovascular procedure and immediate morphological success with < 30% residual diameter stenosis assessed by quantitative coronary angiography (QCA).

  Diameter stenosis is defined as the difference between reference vessel diameter and minimal lumen diameter divided by reference vessel diameter x100%.

• In-segment Late Lumen Loss [ Time Frame: 6 months ]
• Percent in-stent diameter restenosis [ Time Frame: 6 months ]
• Percent in-segment diameter restenosis [ Time Frame: 6 months ]
• Binary In-stent Restenosis [ Time Frame: 6 months ]
• Binary In-segment Restenosis [ Time Frame: 6 months ]
• Cumulative MACE rate [ Time Frame: 1, 6 and 12 months ]
• Type of reoccurrence according to Mehran classification [ Time Frame: 6 months ]
• Technical Success [ Time Frame: directly after intervention (after finalized treatment) ]
• Device Success [ Time Frame: directly after intervention (after finalized treatment) ]

Information By: Biotronik AG

Dates:
Date Received: August 13, 2009
Date Started: August 2009
Date Completion:
Last Updated: May 2, 2013
Last Verified: May 2013