Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH – ISR II)

Coronary Restenosis Clinical Trial

Official title:

Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH – ISR II)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409981
• Other study ID #: BMT - Pac 2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 11, 2006
• Last updated: December 11, 2006
• Start date: July 2004
• Est. completion date: June 2006

Study information

• Verified date: December 2006
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The PACCOCATH ISR II study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.

Description:

Background: Drug-eluting stents have shown promising anti-restenotic effects in clinical trials. It may be preferable, however, to avoid the stent-in-stent approach in treating in-stent restenosis (ISR). In prior animal trials, we demonstrated a highly significant reduction of neointimal formation by drug-eluting balloon catheters (DEB). The aim of the PACCOCATH ISR study is to investigate the novel DEB in the treatment of ISR.

Methods and results: The PACCOCATH ISR study is a randomized, double-blind German multicenter trial on the efficacy and tolerance of the DEB in coronary ISR. Patients are randomized to rePTCA of ISR either using the coated PTCA balloon (3 µg paclitaxel/mm² balloon surface) or a non-coated balloon of the same type (n=56 patients). Balloon inflation time is 60 seconds in both cases. Major inclusion criteria are an ISR in a coronary artery with a diameter stenosis of at least 70%, < 30 mm length, and a vessel diameter of 2.5 to 3.5 mm. The primary endpoint is late lumen loss after 6 months (independent angiographic core lab). Secondary endpoints are binary restenosis rate and major adverse cardiac events.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Clinical evidence of stable or unstable angina or a positive functional study

• Single, restenotic lesion in a stented coronary artery (allowed are multiple lesions but only the target lesion is amenable for percutaneous intervention, i.e. no ‘staged’ procedures involving non-target lesions)

• Diameter stenosis > 70% (visual estimate)

• Stented segment length < 30 mm

• Vessel diameter => 2.5 mm

• Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization

• Signed patient informed consent form

• Patients and treating physicians agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol

Exclusion Criteria:

• Left ventricular ejection fraction of < 30%

• Target lesion/vessel with any of the following characteristics: Clear angiographic calcification in the target lesion or greater than mild calcification in the proximal vessel (minimally radiopaque densities that are discrete and non-linear). Visible thrombus proximal to the lesion.

• Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated.

• Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy causing the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).

• Severe chronic renal insufficiency.

• Significant gastrointestinal (GI) bleed within the past six months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.

• Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and/or requires additional anti-platelet and/or anti-coagulation treatment.

• Participating in another device or drug study within the last 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Restenosis

Intervention

Device:
• paclitaxel coated balloon catheter (device with drug)

Locations

Country	Name	City	State
Germany	Kardiologie, Campus Mitte, Charite	Berlin
Germany	Kardiologie, Campus Virchow-Klinikum, Charite	Berlin
Germany	Medizinische Universitätsklinik III, Abt. Kardiologie und Angiologie	Freiburg
Germany	Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes	Homburg / Saar	Saarland
Germany	I. Medizinische Klinik, Universitaetsklinikum	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13. — View Citation

Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. Epub 2004 Aug 9. — View Citation

Scheller B, Speck U, Romeike B, Schmitt A, Sovak M, Böhm M, Stoll HP. Contrast media as carriers for local drug delivery. Successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003 Aug;24(15):1462-7. — View Citation

Scheller B, Speck U, Schmitt A, Böhm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. — View Citation

Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. — View Citation

Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	angiographic late lumen loss
Secondary	binary restenosis rate; major adverse cardiac events