Thunder Trial - Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries

NCT00156624 | Unknown Phase 2

• 1 other identifier: Pac-2
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The Thunder Trail is a randomized , double-blinded, placebo controlled German multi-centre study on the efficacy of local paclitaxel for prevention of restenosis in the superficial and popliteal artery.

Conditions

Arterial Occlusive Diseases

Keywords

Intervention; Peripheral Vascular Disease; Drug; Restenosis; 18 years and above

Outcome Measures

Primary Outcomes (1)

• Late lumen loss of vessel segment following dilatation after 6 months

Secondary Outcomes (2)

• Thrombotic complications or revascularization of the target vessel, death; adverse reactions known to occur after paclitaxel (high dose tumor therapy except reactions to the detergent)

• Paclitaxel plasma concentration will be determined immediately after administration

Interventions

Balloon Angioplasty with or without drug administration DRUG

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Chronic Occlusions and stenosis (history at least 6 weeks) ≥70 % diameter Stenosis \> 2cm in the arteria femoralis superficialis or arteria poplitea
• Various criteria assuring ethical issues and follow up

You may not qualify if:

• Conditions requiring different treatment or raising serious safety concern regarding the procedure or the required medication.
• Pregnancy can not be excluded
• Doubts in the willingness or capability of the patient to allow 6 months follow up

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Herzzentrum Bad Krotzingen: collaborator
• Humboldt-Universität zu Berlin: collaborator
• University of Greifswald: collaborator

Study Sites (1)

University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (3)

• Tepe G, Schnorr B, Albrecht T, Brechtel K, Claussen CD, Scheller B, Speck U, Zeller T. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):102-8. doi: 10.1016/j.jcin.2014.07.023.

  PMID: 25616822 DERIVED

• Tepe G, Zeller T, Schnorr B, Claussen CD, Beschorner U, Brechtel K, Scheller B, Speck U. High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study. J Endovasc Ther. 2013 Dec;20(6):792-800. doi: 10.1583/13-4392R.1.

  PMID: 24325695 DERIVED

• Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.

  PMID: 18272892 DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases; Peripheral Vascular Diseases

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Gunnar Tepe, MD

  University Hospital of Tuebingen

  PRINCIPAL INVESTIGATOR

• Gunnar Tepe, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2004
• Study Completion: October 1, 2007
• Last Updated: April 25, 2006

Record last verified: 2005-09

Locations

DE (1)