Trial Outcomes & Findings for Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis (NCT NCT00961181)

NCT ID: NCT00961181

Last Updated: 2013-05-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 81 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2013-05-06

Participant Flow

From 14 August 2009 to 26 April 2010 a total of 81 patients at 9 heart centres in Europe were enrolled. Last follow-up was completed 09 May 2011.

No group assignment.

Participant milestones

Measure	Paclitaxel Releasing Balloon Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Overall Study STARTED	81
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Paclitaxel Releasing Balloon Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Overall Study Death	2
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

Baseline characteristics by cohort

Measure	Paclitaxel Releasing Balloon n=81 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants
Age Continuous	66 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Region of Enrollment Germany	67 participants n=5 Participants
Region of Enrollment Poland	9 participants n=5 Participants
Region of Enrollment Denmark	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA

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

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).

Outcome measures

Measure	Paclitaxel Releasing Balloon n=63 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
In-stent Late Lumen Loss	0.07 mm Standard Deviation 0.31

SECONDARY outcome

Timeframe: 6 months

Population: 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA

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).

Outcome measures

Measure	Paclitaxel Releasing Balloon n=63 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
In-segment Late Lumen Loss	0.02 mm Standard Deviation 0.32

SECONDARY outcome

Timeframe: 6 months

Population: 2 patients died, 2 patients withdrew consent

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

Outcome measures

Measure	Paclitaxel Releasing Balloon n=77 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Cumulative Major Adverse Cardiac Events Rate (Composite of Cardiac Death, Non-fatal Myocardial Infarction, Clinically Driven Target Lesion Revascularization, Clinically Driven Target Vessel Revascularization)	5 participants

SECONDARY outcome

Timeframe: 12 months

Population: 2 patients died, 2 patients withdrew consent, 1 patient lost to follow up

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

Outcome measures

Measure	Paclitaxel Releasing Balloon n=76 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Cumulative MACE Rate (Composite of Cardiac Death, Non-fatal MI, Clinically Driven TLR, Clinically Driven TVR)	9 participants

SECONDARY outcome

Timeframe: 6 months

Population: 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA

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).

Outcome measures

Measure	Paclitaxel Releasing Balloon n=63 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
In-stent Diameter Stenosis (%DS)	25.9 percentage of re-narrowing Standard Deviation 11.7

SECONDARY outcome

Timeframe: 6 months

Population: 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA

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).

Outcome measures

Measure	Paclitaxel Releasing Balloon n=63 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
In-segment Diameter Stenosis (%DS)	29.9 percentage of re-narrowing Standard Deviation 10.6

SECONDARY outcome

Timeframe: 6 months

Population: 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA

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).

Outcome measures

Measure	Paclitaxel Releasing Balloon n=63 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Binary In-stent Restenosis	2 participants

SECONDARY outcome

Timeframe: 6 months

Population: 2 patients died, 2 patients withdrew consent, 6 patients refused repeat angiography at 6 months follow up, 8 patients could not be analysed by QCA

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).

Outcome measures

Measure	Paclitaxel Releasing Balloon n=63 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Binary In-segment Restenosis	1 participants

SECONDARY outcome

Timeframe: 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%.

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

Outcome measures

Measure	Paclitaxel Releasing Balloon n=81 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Technical Success	81 participants

SECONDARY outcome

Timeframe: directly after intervention (after finalized treatment)

Device success defined as exact deployment of the device as documented by two different projections assessed by 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).

Outcome measures

Measure	Paclitaxel Releasing Balloon n=81 Participants Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Device Success	80 participants

Adverse Events

Paclitaxel Releasing Balloon

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paclitaxel Releasing Balloon n=76 participants at risk Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
Cardiac disorders Cardiac death	0.00% 0/76 • 1 year On-site follow up at 6 and 12 month follow up. All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee
Cardiac disorders Non-fatal myocardial infarction	1.3% 1/76 • Number of events 1 • 1 year On-site follow up at 6 and 12 month follow up. All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee
Vascular disorders Target vessel revascularization	1.3% 1/76 • Number of events 1 • 1 year On-site follow up at 6 and 12 month follow up. All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee
Vascular disorders Target lesion revascularization	9.2% 7/76 • Number of events 7 • 1 year On-site follow up at 6 and 12 month follow up. All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee
General disorders Non-cardiac death	2.6% 2/76 • Number of events 2 • 1 year On-site follow up at 6 and 12 month follow up. All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee
Vascular disorders Stent thrombosis	0.00% 0/76 • 1 year On-site follow up at 6 and 12 month follow up. All safety endpoint and serious adverse events were adjudicated by an independent clinical events committee

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Christoph Hehrlein

University Medical Center, Freiburg i.Br., Germany

Phone: +49 761 270

Email: christoph.hehrlein@uniklinik-freiburg.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60